Johnson & Johnson

Noticeable increase in menstrual cycle- bleeding increased 6-7 hours post injection, and was accompanied by very large clots. (Not normal ) This lasted two days. Intense chills/shivering. Night sweats, nausea. This was the night of the injection. Headache. Everyday since injection. Throbbing in left temple. Muscular pain, left deltoid. This has increased since day of injection. Redness, swelling, pain at injection site that has intensified since injection. (No other indicators of it being an infection. Not warm to touch, no oozing or bleeding or any type of fluid.) Left forearm muscle pain, left wrist pain- almost like a dull ache going down arm.

Chills/shaking began approximately 8 hours after injection. Other symptoms of an achy upper body, temperature of 103.1, and nausea came shortly after initial symptoms (within 1 hr.). In the middle of the night, I began heavily sweating (something I have never experienced). I was drenched with sweat and needed to change in the middle of the night. Absolutely no energy and a horrible headache. 24 hrs. after the injection I no longer had a high fever. However, consistently for a week, every day, I had at least one symptom (headache, nausea, chills, or lack of energy) at some point throughout the day. When I received the injection, I was on day 2 of my period. It ended one day later than normal. However, what was not normal was that on 4/3/21, I began to bleed again. I passed 2 clots and had spotting for an additional 5 days. This is in no way normal to my cycle.

High fever for 3 days, lost of taste. Stomach pains and heavy menstrual cramps and bleeding. Blood cloths while menstrual cycle.

I went limp in my left arm and side of body. I was shot in right side of arm. I have been having numbness, pain, and soreness on that side. I also had my menastration come on after 12 years - 2 days later of taking the shot for 3 days.

Seemed to very much effect my menstruation. My period came 10 days late, then this month?s period was 2 weeks early. Very bad clotting with menstrual bleeding. I am normally very regular so this was extremely unusual.

body aches, chills, fatigue and malaise, rapid heart beat while sleeping (caught by apple watch 123 beats per minute, sleep rate is usually low 50s to 60), very painful and heavier than usual period that i felt really bad during

Menses always 4-5 days. This menses (first since vaccine) is now on day 14! Flow not extremely heavy but continuous. Huge change from normal.

My first period after the vaccine arrived 6 days early, which is quite abnormal for me. The day before I couldn't work at my desk due to pain in my low back and hip flexors, which is also abnormal. Then the period was heavier than normal lasted 3 days longer than normal. It looked like there were clots in the blood. I mentioned this experience to a friend, who said several of his female friends also experienced bizarre periods after receiving the JJ vaccine. Was this drug tested on women of reproductive age before being released?

Fever greater than 101 for 18 hours post vaccination along with muscle body aches. Regular menstrual cycle followed by 2+ weeks of spotting, headaches accompanied with nausea.

Fever of 102.2, chills, loss of appetite lasting for approximately 24 hours. Ibuprofen 800 given at showing of fever and throughout the symptom process. Menstrual cycle started a week after vaccine which was considered early in my cycle.

My normally regular period (28/29 day cycle, regular for many years), was over two weeks late. Menstruation was due 2/1-2/2 and did not begin until 2/18. Both the duration and flow were normal for me.

Abnormally heavy bleeding during the menstrual period following the vaccination, including a large blood clot (also abnormal)

Period delayed two weeks. My cycle is very regular but after the vaccine it was delayed two weeks from the expected date. Additionally, I had a cold sore outbreak starting on April 11.

My period was delayed in starting/started about 7 days late and then I had menstrual bleeding for 18 days that was very heavy. This is very irregular for me. I did also have a fever of 102.9, myalgias, chills, and joint pain on 3/31-4/1/21 right after receiving the vaccine

7 weeks at vaccination due date 11/14/2021 was due third pregnancy had successful pregnancy, Normal pregnancy and next two days was very sick, body aches, fatigue, Tues. Tuesday 03-30-2021 she experienced bleeding and at that time was 7 weeks 2 days pregnant ER went to the doctor and they indicated that she would need to return, then on Thursday 04-01-2021 she had a miscarriage and it was confirmed that she was having a miscarriage.

Changes in menstrual cycle. 7 days late to begin cycle. Usually lasts 3-4 days and I?ve had heavy bleeding for 9 days and continuing.

I got an extra - extended - period. I spotted and bleed for almost a month after the shot from April 2nd - April 29th. I also had the regular initial symptoms for 3 days after the shot. But that's not my issue. The issue is the extra - extended - period. I don't normally have this problem, my cycles are regular. It's now May 12 and I haven't got my period since April 29th. Hopefully, this is over and I'll return to my regular cycle.

Patient was calling in because she stated she's been taking her Mayzent medication but she believes she may be pregnant. Patient stated she hasn't gotten her period in a couple months and has been spitting up a bit but has not taken a pregnancy test. Patient also stated she recently took the J&J vaccine and didn't know if her current symptoms were related to that.

Vaginal bleeding one week post partum. Due date 4/6/2021. Delivered on 4/11/2021. Healthy boy, 7 lbs 6 oz. Forecept-assisted delivery. Bleeding started one week later. Large amount of bleeding. Three units of blood transfused. In ER/ICU for approximately 40 hours.

The day after my vaccine I started my period. It was close to my usual cycle. It was rather light flow but for a normal duration. 23 days later began another period. It's early. I am now on day 21 of an active flow. On Day's 7-9 I experienced extremely heavy flow, soaking overnight pads in a matter of 2 hours, and experience large blood clots. On day 14 I caught medical attention at my normal primary care clinic through their walk-in services. I was given birth control and told that at my age this was just to be expected. No lab work was performed.

I have my period since I got the shot! Some days it's just one or two tampons a week but, this past week has been several tampons and pads a day(super plus) and still leaks into my clothes several times a day. I have huge blood clots and heavy bleeding constantly 2h/7. Needless to say I am miserable.

I got the shot on the first day of my menstrual cycle. About two hours after getting the shot, I experienced excessive bleeding for the next seven hours. For four of those hours I bled through a Tampon every half hour. In addition, to the bleeding, there was a lot of lower back pain, pain in the hips and general pelvic region.

I'm not sure if related still would like to report complications to CDC. On Wed May 26 I had episode of bleeding during night around 2am. I went to the ER me and the baby was monitored for 24 hrs. Since I had no additional bleeding sent home. On Fri June 4 had the same episode went to the ER I was 37 weeks my doctor decided to induce my labor. I delivered, baby was healthy then I started hemorrhaging. I got to a stage 3 hemorrhaging became more got different shots. I lost a couple liters of blood now I'm doing fine now.

De evening that day I started with chills , throbbing head pain I never have headaches so it felt like fluid building up over the back of my head like it?s swelling and later on I had post nasal dripping massively - muscle aches , pain and swelling of half of the left arm that stood for about 1 week and the day after I deceased rash all over my neck, arm ,chest back and hip Since I seem to have nerve pain in my foot and my left hip and lower back and lower left belly muscles aching badly I have had nasal bleedings sitting in front of the tv doing nothing, I am as well bruising occasional in ca 10-15 cm purple bruises without having a injury , I haven?t had my menstruation for a about 3 months Regulare dizziness lately with no previous event or reason

Injection site is hot to the touch and a different temperature than the rest of my arm and body. My mensuration cycle was delayed by a week.

Fever, chills, body aches, mild headache, fatigue, and menstrual bleeding. Occurred about 10 hours after administration of the vaccine and lasted 24 hours. Tylenol to help relieve symptoms of fever and body aches. Stayed hydrated with water and Gatorade.

The day of and the following day, flu like symptoms- fever (102 at highest) chills, sweats, headache, fatigue, restlessness (had to sit and sway at night because my body could not stay still. loss of apatite, nausea, injection site pain. tightness in head, upper back/shoulder and neck on the side of the injection (left). Everything but the soreness of the injection site and tightness in the muscles on that side lasted about 48 hours. The tight muscles and soreness lasted about a week. *** THREE WEEKS AFTER THE SHOT**** Sunday, 4/12/2021 I woke up and stepped out of bed and my left ankle gave out when I stepped down. Internal rotation, weakness in left ankle. It happened again as I walked shortly after. That day I tripped many times due to weakness in that ankle. When I showered and shaved my legs I realized that I had absolutely no feeling in the left lateral part of my lower leg. It felt like I had a novocaine injection in my leg. I could not even feel a pin prick there. By Friday 4/9/2021 I started to have some sensation, but still decreased sensation and weakness in my left ankle even at this moment. ****4 WEEKS AFTER THE SHOT**** My period started Monday, April 5th, 2 days early. By Friday, 4/9/2021 and through the day and night Saturday 4/10/2021, I had such a heavy period that I kept soaking through tampons, pads, and 2 pairs of jeans. I have never blead like that and could not keep up.

I started my period a week after receiving the vaccine. My period was unusually heavy for several days, with fatigue and cramping at a level higher than normal.

No pain at site of injection. (A) Onset around 8:00 pm on day of injection: chills, shaking, fever (no thermometer was available -- legs, stomach and head were very hot to the touch for about an hour, despite strong chills); strong migraine; sensitivity to light, sound, touch; mild body aches. (B) Menstrual cycle began on time about 2 days after injection, but persisted for 3 days longer than usual. Normal bleeding occurs over 2.5 days, but light bleeding occurred much longer than any time in the previous decade. TREATMENT: (A) Tylenol, warm blankets, heat pad; (B) Ibuprofen 400mg, heat pad (normal treatment)

Night sweats, muscle aches, headache, fatigue, dizziness, lighted headed, brain fog all began less than 24 hours after vaccination. Period cycle started early and was very intense cramps, heavy bleeding, vomiting. To date, the headache, dizziness, light headed, brain fog and fatigue are still being experienced 13 days after being vaccinated. I called a nurse line on 4/16/2021 to talk over my side effects and was told to visit an urgent care center, who then sent me to the ER for bloodwork and an MRI of the brain. Was told all results came back normal, to continue to monitor myself and make an appointment with a primary care physician if I feel the same in week.

Delayed menstrual cycle by 4 days, when started very painful and heavy. Much more clots than usual and lasting longer than usual. Uncomfortable enough to require rest. Still going heavy when it should be tapering off.?

My period was supposed to start on 04/09 the day I got the vaccine. It was delayed until 04/13 when it began to bleed BLACK clotty sticky sludge. It had the appearance and consistency of vegemite or molasses. Black sludge. At first it was extremely heavy with very large black clots. Then it became tiny little black clots suspended in a brown sludge. This continued for 6 days until 04/18. Then on 04/19 my menstruation turned bright red with no clots, but has not abated at all for another 4 days. I am currently today on Thurday 04/22 still bleeding almost 2 weeks after taking the J&J shot. I cannot believe I am still bleeding after 10 full days!!! Never in 30 years of menstruating have I had a 10 day period. I am very scared and upset.

I took the vaccine at 2:10pm on 4/8/21 and 20 minutes later at 2:30pm on 4/8/21 my cycle started a whole week early, which is very abnormal for me. I am bleeding clots of blood for 5 days now with weakness and pains. My normal cycle is very regular and lasts 3 days, the first day is heavy then moderate, then light on the third day i barely need a liner. This has been heavy bleeding with sizable blood clots.

Next day full body red rash, 103-104 degree fever, deep body aches, skin sensitivity, joint pain, headache, brain fog,lasted 4 days, One week later period started with large chicken-egg sized blood clots, heavy flow lasted 2 days longer than typical period for me. Second cycle after vaccine started 4.22.21 with same very large clots, intense cramping and bloating

Approximately 30 hours of sharp chest pain when taking a deep breath or twisting torso from 3am on 4/13 till 8am on 4/14. Period delayed 6 days, starting on 4/21 when it should have started 4/16. This was 34 days between cycles and an irregular occurance.

I did have leg injury in April - and ever since the vaccine, I now have an issue with swelling that won't stop - still have swelling. I was checked with blood clots - and it was elevated so they gave me an ultrasound in leg - no blood clot. Swelling on right leg was enlarged after the vaccine. Two missed menstrual cycles; now I have had the cycle but it's a longer cycle than I normally would have. It's abnormal - the length and flow is off. Spotted for a week before I started bleeding. I had slightly elevated blood pressure after the vaccine - 117/83 usual but it was elevated 141/95 - and it's never high ever like that before. So they had thought I had a potential blood clot. Have an upcoming doctor's appt scheduled.

I woke up 6 hours after vaccination and started getting the chills with a fever of 101.3. I took some Tylenol which brought the fever down for a few hours but it later shot back up to 104. I had a headache, muscle pain, and fatigue. On Monday, I got a sharp pain on the side of my head causing my eyes to hurt. I called doctor who said that it sounded like a sinus infection and prescribed me Azithromycin. Days later the doctor called me and I told him that I wasn't feeling better and was referred to take a Doppler test which showed nothing wrong. I went to another doctor that prescribed me Bactrim which cleared up my sinus infection and I felt a little better. I still feel fatigued, have brain fog, and double vision. I went to a neurologist and was given a CT scan. That was two weeks ago and I never heard about the results. I'm scared to drive because I don't know what will happen. The vaccine also threw off my cycle and I have gained so much weight since my vaccination.

Continued off and on heavy periods/heavy bleeding...this started on 2 June....about two months after receiving the J&J COVID shot (4 Apr)

Have had hot flashes since the vaccine. Normally I am cold at work and home all the time. Hot flashes at random times throughout the month are VERY abnormal for me.... and increased clotting during periods. Feels like menopause set in after the vaccine. I was not having any of these symtoms before.

Since my first menstrual period came after I received the covid vaccine, I have been spotting and passing clots daily in between periods.

Since the vaccination, my menstrual cycles are not the same. They last way longer and I pass very large blood clots that are not normal for me, to the point that I feel very weak. They have been like this every month since, the pain it?s excruciating at times and I?m not someone that complains, but this doesn?t feel normal.

Had breakthrough menstral bleeding this morning. I am 2 weeks away from menstration. Very light spotting.

I experienced blisters/ mouth ulcers within 24 hours of being vaccinated and lower back ache + abdomen discomfort (akin to period pain) within 48 hours.

No side effects until day 5 (Sunday) after vaccination which were: Migraine, nosebleed, light-headed, weakness, easily winded/fatigued, abdominal pain, heavy menstrual cycle, diarrhea. All side effects ended within 24 hours after they started except for heavy menstruation and fatigue.

Heavy off cycle vaginal bleeding 1 week after normal period accompanied by breast swelling, severe weakness and bruising on the knee (not accompanied by any injury)...off cycle bleeding is not something that has ever occurred before so is highly unusual

My period started on the 14th of April as expected. I usually have cramping on the 2nd or third day. It's now my 5th day and I'm experiencing debilitating cramping more than my normal. It's quite worry, because I'm thinking I should be in the emergency room. Also experiencing heavier than my normal flow. I've had to stay in bed for the past 2 days, unable to get any relief. All this is very concerning, usually my cramping would cease at day 2 or 3. This isn't normal for me to experience this level and duration of pain

Menstrual flow has been heavier, lasting longer and with more clots, and more intense cramps. Has continued spotting since the end of menstrual flow, which is also unusual for her.

SHORTNESS OF BREATH; EARLY MENSTRUAL PERIOD; DIARRHEA; LETHARGY; WEAKNESS; NAUSEA; INJECTION SITE PAIN; This spontaneous report received from a patient concerned a 42 year old female. The patient's height, and weight were not reported. The patient's past medical history included stroke, and concurrent conditions included low iron, egg allergy, and pork allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, and expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. Concomitant medications included iron for low iron. On an unspecified date, the subject experienced shortness of breath, early menstrual period, diarrhea, lethargy, weakness, nausea, and injection site pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the nausea, diarrhea, weakness, lethargy, shortness of breath, early menstrual period and injection site pain was not reported. This report was non-serious.; Sender's Comments: v0-Medical assessment comment not required according to standard operating procedures.

Sore arm and rash 4/9 within 12-16 hours of shot. Body aches and low fever for 12-24 hours after shot. Eyelid hives and rash start 4/10 off and on thru 4/22. Saw dermatologist on 4/16. Used elidel 4/10-4/16 was ineffective. Was treated with eucrisa. Somewhat effective but rash clears and returns. Painful menstrual period 4/22. Unusual at my age and with an IUD.

FEELING BAD; SICK; JOINT ACHE; HEADACHE; INJECTION SITE PAIN; SEVERE CHILLS; SEVERE BODY ACHES; TROUBLE REGULATING BODY TEMPERATURE; HOT AND COLD FLASHES; SEVERE BREAST TENDERNESS; INCORRECT ROUTE OF DRUG ADMINISTRATION; This spontaneous report received from a patient concerned a 42 year old female. The patient's weight was 175 pounds, and height was 155 centimeters. The patient's concurrent conditions included drug allergy, alcoholic, and non-smoker, and other pre-existing medical conditions included patient was not pregnant at the time of reporting. the patient was not breastfeeding at the time of vaccination. no history of drug abuse. the patient had no illness at the time of vaccination. no history of similar event in the past. the patient had no adverse events after any previous vaccination(s). the patient was allergic to amoxycillin. no pre-existing acute illness prior to vaccination. no history of hospitalization 30 days prior to vaccination. no family history of any disease relevant to vaccination or allergy. The patient was previously treated with amoxicillin for drug used for unknown indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intravenous, batch number: 1805022 expiry: UNKNOWN) .5 ml, administered on 08-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-MAR-2021, the subject experienced incorrect route of drug administration. On 08-MAR-2021, the subject experienced severe body aches. On 08-MAR-2021, the subject experienced trouble regulating body temperature. On 08-MAR-2021, the subject experienced hot and cold flashes. On 08-MAR-2021, the subject experienced severe breast tenderness. On 08-MAR-2021, the subject experienced severe chills. On an unspecified date, the subject experienced feeling bad, sick, joint ache, headache, and injection site pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe body aches, trouble regulating body temperature, hot and cold flashes, severe breast tenderness, and severe chills on 22-MAR-2021, was recovering from sick, had not recovered from joint ache, headache, injection site pain, and feeling bad, and the outcome of incorrect route of drug administration was not reported. This report was non-serious. This case, from the same reporter is linked to 20210318992.

Extremely heavy and painful menstruation one week after shot. It was abnormal for me to be that heavy with flow and to even have cramps, let alone that strong.

24 hours after rec' the vaccine she had started her cycle with blood clots. Her cycle did not come on that day. She had to use the bathroom no matter what time for it to come on. Doctor office, Doctor perfomed a series of lab test. Doctor states that she is getting blood clots and think it may be from the vaccine. SHe had her cycle for 16 days straight and now has become anemic.

notes: times are approximate. I got the vaccine on day two of my period. I moved my arm a lot after getting the vaccine. My arm did not hurt, even though the rest of my body ached. 4-27-21 2:45pm: got the vaccine in my left arm. 4pm: felt fine. slightly more energy, clearer head than usual. this good mood and clear head only lasted a few hours. it ended before other symptoms began. 9pm: minor body aches, but not in arm where I got the vaccine. minor chills, shivering. 10pm: began to feel worse. moderate body aches, chills, dizzy. 10:40pm: suddenly felt much worse. severe chills, shaking, dizzy, then felt very hot, nausea. vasovagal syncope. sudden low blood pressure. did not actually faint since I know how to prevent fainting. took ginger, drank a lot of water, got ready for bed. lying in bed. felt nauseas for a few hours. this was the most uncomfortable symptom. frequent peeing. thirsty, but water went right through me. sweating. could not really sleep, not totally awake either. felt horrible. after a few hours, still lying in bed. nausea mostly went away. headache, muscle pain in jaw and face were the worse symptoms at this time. frequent peeing. thirsty, but water went right through me. sweating. felt like someone had turned the heat up. when I checked, the heat was off. felt like I had a fever for a few hours. 4-28-21 1:45pm: got out of bed. feel better than the previous night, but generally unwell. short of breath when moving. fatigue. 6pm: dizzy, weak. 4-29-21: 3pm: mild headache, feel mildly hot. 4-30-21: 10pm: tense muscles, especially in my face and head. 5-1-21: sore breasts. 5-4-21: hormones feel unbalanced. PMS symptoms, but it is a few days after my period ended. intense negative moods, spotting, sore breasts.

KNOT ON THE BREAST; MOOD SHIFTING; HEART RACING; FELT SICK; VARICOSE VEINS AGGRAVATED; SLUGGISH; FELT HOT; SWEATING; DIZZY; SORENESS IN EXTREMITIES; HEAVINESS IN EXTREMITIES; COLLAR BONE PAIN; This spontaneous report received from a patient concerned a 42 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included varicose veins, and other pre-existing medical conditions included the patient was not pregnant at the time of reporting. breast cancer runs heavy in the family. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, and expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 11:30 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced collar bone pain. On 01-APR-2021, the subject experienced soreness in extremities. On 01-APR-2021, the subject experienced heaviness in extremities. On 02-APR-2021, the subject experienced varicose veins aggravated. On 02-APR-2021, the subject experienced sluggish. On 02-APR-2021, the subject experienced felt hot. On 02-APR-2021, the subject experienced sweating. On 02-APR-2021, the subject experienced dizzy. On 02-APR-2021, the subject experienced felt sick. On 03-APR-2021, the subject experienced heart racing. On 17-APR-2021, the subject experienced mood shifting. On 03-MAY-2021, the subject experienced knot on the breast. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt hot, sweating, dizzy, and heart racing on 2021, was recovering from sluggish, and varicose veins aggravated, had not recovered from soreness in extremities, knot on the breast, and heaviness in extremities, and the outcome of mood shifting, collar bone pain and felt sick was not reported. This report was non-serious.; Sender's Comments: V0. Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.

I started by menstrual cycle 16 days early which was 3 days after receiving the vaccine. Today is 24 and I am still bleeding -some days light some days like my regular period

The day of and the first week after I only felt a little lightheaded. Seven days after the vaccine I began having dizzy spells, extreme fatigue and nausea, blurred vision, extreme right head pressure, floaty sensation, numbness and tingling in my right arm and leg, muscle spasms, and extreme anxiety. All things I have never experienced before. And they have persisted daily since they began. My first period one week after the injection was a couple days late and very light and only lasted a few days, which is also not normal roe me. I have short periods of relief and then the symptoms return. It is very scary and I need help. I have been to my pcp several times and the Er. They can?t explain my symptoms.

I was sick feeling for three days after. My periods have been coming every two weeks, and the last one has lasted 22 days.

First period following vaccine was 10 days early and was an extremely heavy cycle, instead of changing pads every 4-5 hours, I had to change consistently every 2ish hours. Second period following vaccine started 30 days after the period immediately prior, but was extremely heavy. On the last full day of my period, around 11:30 am, my body discharged very large amounts of blood. Soaking through my underwear, my jeans and all over my car seat. I used the restroom shortly after this discharge, prior to getting in to the shower, and upon wiping, realized I had passed a baseball size mass of tissue or gel like substance. After this ?peak activity?, my period continued as normal and finished the following morning.

I had a break through period 15 days into my cycle which is not normal, I saw my obgyn because I was concerned. My cycle was abnormally heavy and long.

LETHARGIC (FATIGUED,VERY TIRED,UNABLE TO GET OUT OF BED); WINDED FROM WALKING AND RUNNING; PERIOD DELAYED BY 2 WEEKS; This spontaneous report received from a patient concerned a 42 year old female. The patient's weight was 130 pounds, and height was 66 inches. The patient's concurrent conditions included social drinker, non smoker, and copper iud, and other pre-existing medical conditions included the patient had no known allergies and had no drug abuse or illicit drug usage. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 1805020, expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, the subject experienced period delayed by 2 weeks. On 26-APR-2021, the subject experienced lethargic (fatigued, very tired, unable to get out of bed). On 26-APR-2021, the subject experienced winded from walking and running. The action taken with covid-19 vaccine was not applicable. The patient recovered from period delayed by 2 weeks, had not recovered from lethargic (fatigued,very tired,unable to get out of bed), and the outcome of winded from walking and running was not reported. This report was non-serious. This case, from the same reporter is linked to 20210537334.

Cessation of monthly menstrual cycles following vaccination. Cycles were regular prior to vaccination; no other signs of peri-menopause. Cycles have not restarted as of 3 months following vaccination. Abnormal hair loss started about one month after vaccination and is ongoing.

Before getting the J&J vaccination, menstrual periods lasted 2.5 days. The first full period after vaccination, my menstrual periods are now lasting 5 days or more and the blood consistency is much thicker and darker than previously.

After getting shot I started experiencing PMS symptoms earlier than normal but my period never arrived. I still have not gotten my period and estimate I am now two weeks behind my normal schedule. I have tested negative on a pregnancy test. The past approximate two weeks my breasts have felt swollen, tender, and somewhat painful.

I experienced menstrual spotting outside of my menstrual cycle for about a week after I received this vaccine. After determining that many other women receiving a COVID vaccine experiencing this I was advised I should report this event.

pt says her right arm hurt for a couple of days since taking the vax and has become very fatigued. She had some chills and nausea. She then started feeling like she was going in and out of consciousness. This happens when she has not have enough sleep since due to the fatigue. She says she started her menstrual cycle and it is much heavier than normal and came two week early. She says she still has these symptoms and is concerned.

Very sore and tender breasts. Started on my left side but now seems to be on both. Had a breast exam last week and no lumps. I have a mammogram scheduled for next week.

Not sure if this is related to the vaccine, but my monthly cycle was very much thrown off after I received my single dose shot. Shot received: 3/12/21 Menstruation occurred on time: 3/15 Menstruation occurred again: 4/1

Menstrual cycle came on 10 days early, extremely heavy and lasted for twice as long as normal. Also severe dizziness started 48 hours after vaccine and has not subsided.

JOINT PAIN; INFLAMMATION OF THE RIBS; VAGINAL BLEEDING/CLOTS; CYSTS ABOVE THE LEFT ELBOW; FATIGUE; ANXIETY (TINGLING ALL OVER THE BODY ESPECIALLY THE WAIST, SHORTNESS OF BREATH, WEAKNESS); BACK PAIN; NECK PAIN; This spontaneous report received from a patient. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol consumer, and non-smoker, and other pre-existing medical conditions included patient had no known drug allergies, no relevant medical history prior to the start of these symptoms. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, expiry: UNKNOWN) dose was not reported, administered on 27-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-JUL-2020, Laboratory data included: COVID-19 PCR test (NR: not provided) Negative, Negative. On 2021, Laboratory data included: Biopsy (NR: not provided) Not reported. On 28-MAR-2021, the subject experienced anxiety (tingling all over the body especially the waist, shortness of breath, weakness). On 28-MAR-2021, the subject experienced back pain. On 28-MAR-2021, the subject experienced neck pain. On 30-MAR-2021, the subject experienced fatigue. On 31-MAR-2021, the subject experienced vaginal bleeding/clots. On 31-MAR-2021, the subject experienced cysts above the left elbow. On 05-APR-2021, the subject experienced inflammation of the ribs. On 06-APR-2021, the subject experienced joint pain. Treatment medications (dates unspecified) included: paracetamol, salbutamol, norethisterone acetate, trazodone, and hydroxyzine embonate. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from cysts above the left elbow, and had not recovered from back pain, neck pain, anxiety (tingling all over the body especially the waist, shortness of breath, weakness), vaginal bleeding/clots, joint pain, fatigue, and inflammation of the ribs. This report was non-serious.

DIZZINESS; OUT OF REALITY; EARLY MENSTRUAL CYCLE WITH HEAVY FLOW; ARM PAIN; FATIGUE; NAUSEA; OVERALL WEAKNESS; This spontaneous report received from a patient concerned a 43 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202a21a, expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced dizziness. On APR-2021, the subject experienced out of reality. On APR-2021, the subject experienced early menstrual cycle with heavy flow. On APR-2021, the subject experienced arm pain. On APR-2021, the subject experienced fatigue. On APR-2021, the subject experienced nausea. On APR-2021, the subject experienced overall weakness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fatigue, and overall weakness, and the outcome of dizziness, arm pain, nausea, out of reality and early menstrual cycle with heavy flow was not reported. This report was non-serious.

fatigue, chills, body aches, brain fog, difficulty concentrating, chest pains, earlier menstruation, pain at injection site into arm, back and chest. Sought treatment due to chest pains.

Mon 4/12/21 - Headaches started and have continued daily. Tue 4/13/21 - Soreness in right calf muscle, continued for 4 days. Headache continued. Wed 4/14/21 - Sharp pain in pelvis (right and left side) same location I experienced pain the day of receiving vaccine. Occasionally felt this pain 2 or 3 times / day for 2 days. Sought medical attention at ED on the advice of our Nurse Call Center. Was evaluated for blood clots, none found on this day. CT scan, ultrasound of both legs, blood tests. Returned home with directions to take Extra Strength Tylenol for headache. Thu 4/15/21 - Shooting pain in random parts of my body, mostly legs and arms. Experienced throughout this day only. As of 4/27/21, 22 days after being vaccinated, I am still experiencing headaches. More noticeable when I am exerting myself - walking outside for 1-2 minutes triggers the headache. Headaches are usually located in the lower back of my head. Before being vaccinated, I would experience less than 1 headache per month, and they go away within the day.

First period came one week earlier, never had this my whole life and a really heavy period with headache for two days. Very new for me.

3 days after the vaccination I started my menstrual cycle even though I had already had one 10 days before. My menstrual cycles are very regular and this was not normal to start it so soon after the previous one. The cycle that started 3 days after my vaccination was lighter than my normal cycles and only lasted 5 days (as opposed to 7-8). 6 days later, I started spotting again. It only lasted 2 days that time and was very light spotting.

Janssen COVID-19 Vaccine EUA I got the vaccine the evening of 03/23/21. Overnight I noticed my body starting to hurt and felt chills. The morning of 03/24/21 I woke up with full body aches, chills, and fever over 100 F. These symptoms lasted all day. Fever went up to 102 F. Recently I have noticed a change in my menses since having the vaccine and I wonder if it is linked. I have been on birth control since last year to control heavy bleeding. It was helping very well. The period I had in April and May were like it was before I started the pill. It was heavy and I had numerous large clots. I will be scheduling an appt with my ob/gyn regarding this change.

The day I received my shot I had a fever and chills 2 hours later. I started my period on Sunday 04/11/2021 and I couldn't stop bleeding . plenty of blood clots and fever. I called my Dr and he called medicine in and after 3 days the symptoms stopped . I had a Dr appointment on 4/27/2021 and my iron was very low and blood pressure was at stroke level. I go back to the Dr. in 3 weeks for blood work.

NUMBNESS IN LEGS; FEELS LIKE EXTREMITIES FALLING ASLEEP; MILD CHILLS; IRREGULAR MENSTRAL CYCLE; This spontaneous report received from a patient concerned a 43 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included thyroid problems, and other pre-existing medical conditions included the patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination.. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced irregular menstral cycle. On 05-APR-2021, the subject experienced mild chills. On an unspecified date, the subject experienced numbness in legs, and feels like extremities falling asleep. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the mild chills, irregular menstral cycle, numbness in legs and feels like extremities falling asleep was not reported. This report was non-serious.

5 days after my shot, I began to bleed. I continued to bleed vaginally for 5 days. have been post menopausal for about 2 years.

High fever, intense headache first 4 days Major hormone disruption: heavy menstrual bleeding 10 days prior to expected period ; impact on energy, mood; swollen breasts/nipples. Bleeding stopped, other symtpoms weakening but not entirely gone. Not due next period yet (assuming it will arrive my normal 29 days from the vaccine-induced bleeding). Context: Not pre-menopausal Regular, light/average bleeding, never early Generally well, fit and healthy

For the first time in my adult life, I missed a whole period the month after the vaccine - the month of April.

I take birth control that doesn?t have a period and I have started spotting. Everyday since it began.

injection site pain/soreness: immediately during dose until 5 days after tinnitus: 22-36 hr post dose nausea: 22-36 hr post dose joint aches: 22-36 hr post dose tiredness: 36-72 hr post dose low grade fever (99.5 - 100.5 F): 37-72 hr post dose delayed or skipped menstrual period

14.5 hours after receiving vaccine, I received my depo-provera birth control shot in my opposite arm, 1.5 hours later the side effect of chills started, sore arm, then 4 hours later a fever of 100.4, the fever broke 28.5 hours after my vaccine, additionally the same day as the chills and fever my period which had just finished, returned and was extremely heavy with bad cramps, my arm was sore for 3 days after starting on the second day after vaccination.

Notice lumps in left side/center of left breast within two weeks of JNJ COVID-19 vaccine during breast self-check exam at home. The site was also very tender to the touch and remained sore after touch. Attempted to schedule my annual mammogram on 4/2/21; I was directed by radiology scheduler to PCP to confirm whether I would need a diagnostic versus screening mammogram due to what I was detecting. I went to my PCP to inquire about symptoms on 4/7/21. By that time, the lumps and soreness was much less detected. I was advised to schedule a mammogram at least 6 weeks post-vaccination.

Employee reported on 4/16 that after receiving the J&J vaccine she was having uterine contractions and pelvic pain. She went to her primary which put her on baby aspirin. Employee then called out for chest pain on 4/20. She went to the ER on 4/19/21 . ER stated she did not have a blood clot and it was muscle related. She was put on medication. She was put out of work for 3 days. Upon her return on 4/23 she returned to work and stated she was advised by her primary to get an MRI.

I had my period on 4/9 at the time of vaccine and have it again as of 4/23 which was only 14 days later and this has never happened before. I thought it was worth reporting

My first menstrual period following the vaccine was exceedingly heavy in flow for the first two days, which is atypical for me. Heavy clots of menstrual discharge were observed. It is not yet known whether these side effects will continue for my next menstrual cycle. Lesser effects followed two days after the vaccine with fatigue, sore arm, armpit, and glands in the injection arm. These side effects dissipated by day 3 status post vaccine administration.

At the time of vaccine, I was on my last day of my period 4/8/2021. My period stopped on 4/9/2021-4/10/2021. Then on 4/11/2021, I started having heavy spotting which quickly turned into a very heavy bleeding and has not stopped since. I have been bleeding heavily since 4/12/21 and it is now 5/5/21.

The vaccine affected my menstrual cycle. I was 10 days late for my period. I am a 26 day cycle. My period came on day 36 instead.

So within ten minutes of receiving the vaccine, my chest area was completely covered in hives. It started off small and then covered my chest, I walked over to the nurses and they called the EMTs. They checked me and my throat to make sure it wasn't closing up. Within twenty minutes it started to go down (the redness). In an hour I had some tingling all over my body. I spoke with my PCD the day after the vaccine and then physically saw her. Now we are much after the vaccine and I see a neurologist suggested by my PCD, because I have random numbness in my fingertips and body and I also experience a lot of fatigue, very tired regularly. I also had a delayed menstrual cycle for about a week. I also felt cramping on my fingertips and toes.

cycle lasted for 12 days First 2 days was extremely heavy soreness at injection site and it felt numb headache and cough Unsure if the below information is related: I though I had Food poisonous severe cramping sweating

My period was 2 days late with no pre-spotting like I normally get. Period came two days late with only 1 gush of blood then it completely stopped for an entire day. Now I am spotting/shedding but not a period.

HEAVY MENSTRUAL BLEEDING; EARLY MENSTRUAL BLEEDING; This spontaneous report received from a patient concerned a 44 year old female. The patient's weight was 119 pounds, and height was 65 inches. The patient's past medical history included miscarriage, and concurrent conditions included pollen allergy, mold allergy, cedar allergy, mollusk muscles and clams allergy, alcohol user, non-smoker, endometriosis, fertility difficulties, and cyst on ovaries, and other pre-existing medical conditions included the patient had no drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A expiry: UNKNOWN) dose was not reported, administered on 11-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-JUN-2021, the subject experienced heavy menstrual bleeding. On 11-JUN-2021, the subject experienced early menstrual bleeding. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from heavy menstrual bleeding, and early menstrual bleeding on JUN-2021. This report was non-serious.

I suffer from a genetic condition called Hereditary Angioedema. Prior to preventative medicine (Tahkzyro) availability, I treated each attack acutely with Firazry/Icatibant. My swelling attacks were rare (no more than 6 times per year, and one injection stopped the attacks. When Tahkzyro was approved as a prevention (every two week injection), in Oct. 2018, I began to administer this medicine 2x per month. This eliminated ALL attacks to my extremities, but not to my abdominal area. Those attacks were reduced to 4/yr, with a recurrence of attack within a day of first attack. Firazry/icatibant had to be injected again (after six hours) and within a day, the attack would stop. Tracking my triggers, I found consistency in the following (all three situations would have to be present). 1. Near my menstruation cycle. 2. Some viral-like symptom (scratchy throat/allergy, virus/illness). 3. Some stressor (activity, emotional, or weather-related). None of these things, alone, set off an attack. They have to occur around the same time. My Johnson and Johnson vaccine was administered on March 18. My period was due on April 3. My period is 95% on time, always. Depending on the timeframe for PMS/horomones, I would say that the injection was proceeded by my body entering into this phase. On Mary 21, I experience my first abdominal attack in 6-8 months. I injected Icatibant and after 6 hours, had to inject again due to a recurring attack. I ordered a refill on my injections. On April 2, I travelled to for vacation. On April 4, I experienced the first of several abdominal attacks. I ran out of medicine and had to have a new order shipped to my hotel (this had never happened before). My menstruation was also late. By April 9, my menstruation arrived, with a flow extremely higher than I recalled ever having in my adult life. My abdominal attacks also ceased by that point. I believe that having received this vaccine (which I am told has some form of the virus), during my PMS stage, along with over exerting myself with activities, created the three situations that occur to create a very painful, debilitating, abdominal attack.

Vaginal spotting 24 hours after vaccination , on 4-9-2021 Headache, arm soreness noted 48 hours after vaccination, lasting ~ 24 hours , noted 4-10-2021 Bruise at site of injection noted on 4-12?may have been present prior to this date but went unnoticed

Later on that evening I started feeling tired, chills, & fever. This lasted about 4 days on the 2nd or 3rd day I had a swollen lymph node under my left armpit. It lasted just a couple of days. On 3/21/2021 I missed my period I did not get it the month of march. Now on the month of April I first started spotting on April 7th it was very light then it went heavy till this day 4/13/2021 I'm still bleeding which is not normal because my period normally only lasts for 4 days. On 3/31/2021 I also had chest pain that lasted for 4 days then it started subsiding. On 3/12/2021 and on 04/11/2021 I got a weird abdominal pain that lasted for less than 5 minutes.

Started my menstrual cycle 6 days early, heavier than normal and increased cramping. Also, many small clots being expelled

I had all the symptoms of the Flu for 3 days, fever, muscle pains, cough, fatigue, and on the 4th day I started having horrible cramps, felt like labor/contractions, followed by my period, which wasn't due for another 3 weeks. I'm still having a very heavy flow and horrible cramping a week later.

Period delayed 1 week. Spotting for first 3 days then super unusually heavy Vertigo - going on for 2 weeks now

On 4/12 I started exp pain in legs shooting pain to my thighs and fatigue. I contacted a friend doctor stated that doesn't sound right might be a blood clotting issue. I went for a visit on 4/13 in the clinic doctor said it seem ok. I was also exp nausea, headache and pain lower left leg. I went to the hospital on 4/14 had Blood Work, Ultrasound (legs) tests results was fine. Also still exp inflammation feeling in my legs a if I have lifted weights and tightness in my calves. I couldn't walk exp muscular pain, stiffness between 4/14-/4/16. I normally have my menstrual 3-4 days for some reason it started over again on 4/10 for 10 days. I'm not sure if this was some sort of hormonal reaction. My normal daily activities have been limited I usually walk every morning with my husband since vaccine not able.As of 4/19 my headache is gone the pain is not as bad in legs.

- unexpected, extremely heavy period with an amount of blot clots similar to what is passed after just giving birth - fatigue, nausea, light headedness

Severe diarrhea and abdominal cramping. Lasted about 1.5 hours. Sudden, unexpected start of menstrual period. Heavy blood flow. Body aches and chills. 10+ hours

4/1 J&J Vaccine, exactly 7 hrs later, intense chills, woke up next morning a-okay 4/3 A few min after waking up, itchy wrists (bilateral), then itchy shins (bilateral), last about 20min 4/5(?) Possible tick (on back - couldn?t really see or reach, scratched at it?) 4/10 Back pain/extreme tightness (fascia from back of knee to upper back feels like sheet of hard leather, extremely limited forward flexion, maybe 50% of normal?) 4/11 Painful intermittent scalp spasms over left ear for 2-ish hours 4/17 Hypersensitive mucus membranes 4/18 Right side of face falls down - Bell?s Palsy? 4/19 Weird hard-leather back pain fading 4/20 ?Headache? - actually feels like seizing scalp muscles behind top of ears 4/20 ?Cold? spots on skin, particularly legs 4/20 Painful knot (familiar) mid/upper right side 4/20 Out of breath 4/21 Leatherback returns 4/22 Awake 3am head pain back of right ear down neck 4/22 Awake 3am - I can feel my face! (BP resolving) 4/22 Extreme pain during asana, leatherback, shakey, lightheaded, out of breath, severe brain fog (almost hallucinatory) 4/23 Awake 1am extreme head, upper right back pain 4/23 Cold spots front of thighs above knee and left foot 4/24 Weird right upper arm/shoulder pain (hours after carrying around a dozen-ish 100lb-ish rocks) 4/25 Awake 1am -6am in extreme insanely excruciating pain right arm (upper/outer/upperback-ish) paced house for 5 hrs. Tylenol & vicodan useless 4/25 Period 2 weeks early (prednisone?) 4/28(ish) Starting to feel increasingly yeasty (doxy?) 4/29 Last day prednisone (accidentally took 1 extra day, grr) 4/29 Extreme weakness and pain - right arm utterly crippled, shoulder partially paralyzed??? (acute and continuous still as of 5/19) 4/29 Very off balance 4/29 Very jittery 4/29 Emergency visit with Dr (Grrr.) 4/30 Left bicep totally dead with pain like an ice pick through it, extreme weakness (pain, limited mobility and some weakness continuous still as of 5/19) 5/1 I can see in my notes that I am switching words!?! (left for right) ?someone mentioned to me on May 2(?) that I was switching left for right? 5/3 Dr video appointment 5/5 Brain fog approaching hallucinatory (hard to explain, everything around me slightly ?fun-house mirror-esque?, judgement is vey skewed, not fun!) 5/7 Last day doxy

HEAVY VAGINAL BLEEDING WITH CLOTS; SPOT; This spontaneous report received from a patient concerned a 45 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included hypertension, and other pre-existing medical conditions included the patient had no known allergies. the patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, expiry: UNKNOWN) dose was not reported, administered on 13-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-MAY-2021, the subject experienced spot. On 29-MAY-2021, the subject experienced heavy vaginal bleeding with clots. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from heavy vaginal bleeding with clots, and the outcome of spot was not reported. This report was non-serious.

I developed ITP and was hospitalized June 2-4 to stabilize my platelet numbers after hemorrhaging on my period for the second month in a row.

On first period after vaccine, experiences heaviest bleeding I have ever had, huge blood clots the size of golf balls, and I had severe cramping and body aches for three days of my period. Previous to vaccine had heavy bleeding, but not this heavy and only one evening period period cycle of light cramping and mild body aches. I have become anemic since the vaccine.

Pelvic achiness 18 hours post vaccination. Having vaginal bleeding/spotting 24 hours post vaccination. Am currently on beginning of week 3 of birth control pills - normally have no issues with spotting - always very consistant.

in about 5 hours after the shot, I started having very strong chills, body aches, headache, nauseous, eyes hurt, abdomen pain. Symptoms continued for about 20 hours (bed rest, not capable to do anything). horrible headache at night time. No fever. Felt chills and feeling hot sweating during the night. Took Tylenol 2 times. dull pain in the shot area, pain distributed under arms around breasts. tender breast and nipples on 3rd day (Sun) after the shot. Lost appetite for about 2 days (body weight 3 pounds less).

4/6 night of i had night sweats all night 4/7 woke up horrible headache and body aches 4/8 really really bad headaches and body aches 4/9 weakness, nausea, dizzy tiredness 4/10 weakness, nausea, dizzy slept all day 4/11 started a period. I have already gone through menapause and haven't had a period in over 3 yrs.

First day of menstrual cycle has produced large clots and severe cramping. Normally my periods are light with zero cramps. I was in so pain today I was unable to work even after taking 1200mg of ibuprofen

I received my shot around 5pm on April 7th at the pharmacy. My left arm was a little sore and I felt a bit woozy but aside from that everything seemed okay. Approximately 5-6 hours after my vaccine my period started back up which was strange as I just finished my cycle on Friday, April 2nd. My period was pretty heavy in comparison for the first 3-4 days and then finally stopped again on Sunday, April 11th. I am 1 week past my vaccine and everything seems fine for now and I hope it continues.

Received Janssen vaccine 4/6. Started menstrual cycle 12 hours after vaccine even though had just completed last cycle 1 week prior. Normally cycles are 28-30 days apart. They have not been quite as regular since Covid and has had some shorter periods between normal cycles. After the vaccine bleeding was heavier than normal with large clots but by end of last week had changed color and looked like it was ending. Today had no discharge upon awakening but again has a small amount of bright blood. Of course, there is concern for coagulopathy related to the vaccination. No leg pain, no shortness of breath. Has had HA off and on since had Covid but no worse now than in previous weeks. Left ear pain has been painful since Covid but now has pain in both ears when that occurs. Quit taking ibuprofen last week for discomfort and switched to Tylenol.

I received the Janssen vaccine on 3/5/2021. My first menstrual cycle after the vaccine, which started on 3/21/21, was significantly different than any other period. I woke in the middle of the night to extreme pain in my abdomen and bled along the floor as I walked to the bathroom. There were clots in the blood in addition to extraordinarily heavy blood flow. The period was so significantly different from any other that I scheduled an appointment with a nurse practitioner that works with my primary care doctor. I asked her to "run" all tests that were available and approved by insurance, which she did. All came back normal. Due to the significant difference in my period this month, the ARNP requested an inner-uterine ultrasound which found the below:

Spotting one day after shot and now 3 days after moderate vaginal bleeding. I have an IUD so I do NOT get periods or have vaginal bleeding.

Effect 1: About a week(5 days or so) severe pain in left leg from the knee down and ankle. Severe as in can?t stand the pain and feels like the leg from the knee down to ankle was being cut off. Effect 2: got my period 7 days after the vaccine was given and it hasn?t gone away. Heavy bleeding and fatigue. I typically don?t get a period and am irregular so this is not normal for me personally.

BODY ACHES; MENSTRUAL CRAMPS; DIARRHEA; CHILLS; FEVER; HEADACHE; TIREDNESS; This spontaneous report received from a parent concerned a 46 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) .5 ml, administered on 01-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 02-APR-2021, the subject experienced body aches. On 02-APR-2021, the subject experienced menstrual cramps. On 02-APR-2021, the subject experienced diarrhea. On 02-APR-2021, the subject experienced chills. On 02-APR-2021, the subject experienced fever. On 02-APR-2021, the subject experienced headache. On 02-APR-2021, the subject experienced tiredness. Laboratory data included: Body temperature (NR: not provided) 102 F. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, menstrual cramps, diarrhea, chills, fever, headache, and tiredness on APR-2021. This report was non-serious.

The same day I took vaccineon April 6, 2021, I had pelvic pain and cramping that increase over the next two. Weeks. I made a appointment with my physician. On 4/29/2021 I was examined by my physician and was told to go to the ER. I had my appendix removed ans the pathology report showed that I had a bllod clot.

2 weeks after receiving johnson and johnson vaccine I began a second period in one month. I am very regular with my menstrual cycle so it was weird. And what is very strange it has large clots and not alot of bleeding. I have never had an period like that since I am 11 years old.

Two nights after the vaccine on the site, it was the size of a pimple on 04/30/2021. After that day everyday I woke and it grew, inflamed, it was firm lump to about inch and half near injection site, and grew overnight larger it was red, swollen and painful. Called my dr on 05/02/2021 and did not hear back from him at all. The lump ended up being the size of my hand, I placed iced on it, and it has went down. Each day since, I have iced it and it has gone down each day. During this time, my period it was very heavy flow for 8 days, then it stopped then began again 9 days later and lasted 7 days heavy flow again.

Injection site is red and swollen. Left armpit to upper side of left breast is swollen and hurts when pressed. I received the shot on Sunday afternoon and by Monday morning my armpit was slightly swollen but went away late morning. Today, Tuesday morning the swelling came back and is considerably larger and has not gone away yet.

On 04-24-2021 I had four days of extreme headaches that would not go away so I went to the ER where I got checked out. Also on 03-28-2021, I woke up with extreme left leg pain. I had difficulty holding things with my arms and I almost collapsed to the floor due to my left leg pain and weakness. I also had heavy menstrual bleeding with giant clots for the Month of March 2021. I can say today I have no symptoms of my left leg or headaches today.

1 or 2 days after vaccination administration - tender & swollen breasts ( bra no longer fit & was visually obvious to family & close friends ) - lasted about 10-14 days. Menstruation delayed about 2 weeks. Menstruated (very light ) for a few days ( usually 7 days) then mensuration stopped for a week and resumed for a few days. I had no other side effects at all & usually do very well with vaccines. I wasn?t going to mention it - figured- no big deal due to my age (possibly pre-menopause), but then a friend told me that 2 of her co-workers (RNs) had experienced noticeable changes to their cycle as well & I figured I should report it - thinking of younger women & reproduction. My cycle has been unpredictable since - maybe menopause- but observed the coincidence

Weirdly despite a right arm injection - left arm ache and left thigh muscle spasms started a few hours afterwards. At 7pm heavy sweat and slight fever. During course of evening nausea, neck, shoulders and lower jaw severe ache by morning. Small sores (the little bubble kind) similiar to mild food allergy broke out on inside bottom lip only and passed only when soreness left lower jaw near late afternoon. Felt better by 5pm. Slight muscle aches in left arm, shoulders & tiredness remained through following day April 2. As of today, 4/12 - I'm having the heavy flow menstral cycle of a freaking teenager. Not fun. I'm accustomed to a very light period at my age not the uteras ripping heavy flow of those first 20 years. Hoping this is a one time deal.

About 4 days after I started having abdomen pain, it was like having contractions, then bleeding and spotting, and it was a different type of color instead of a period color, more burgundy. it lasted 26 days, when I'd eat it would start again, I started having headaches, and had vision problems, then SOB started and I used the inhaler to help. I also had a low grade fever of 99.8 - 100 that lasted up until about 5 days ago. I started having bruising and leg pain, the bruising would be if someone helped me get up, I have little bruising dots over my body. I went to the ER 3/16/2021 because the stomach and headache pains, they did a MRI and Ct and said it was acute stomach pain and migraines and told me to see a OBGYN for the bleeding and gave me meds for stomach pains. Bentel for stomach and Floraset for headaches but it never worked. I had a nerve block on my head for the migraines but it didn't work. The GYN gave me something to stop the bleeding and she's wants to do a D&C. I'm waiting to see my PCP on the 19th. I still have the purple dots and headaches, I still get the contractions and the stomach issues have settled some.

I am a menopausal woman with last date of period August 2019. On 4/7/21 I developed abdominal bloating and cramping related to menstruation. On 4/8/21 I developed mild mucous vaginal discharge with blood streaks. Thereafter, I developed tan discharge for a few days. I've continued to have upper GI pain for the next 2 weeks. I went to the ER on 4/18/21 for lab work up and they performed a right upper quadrant Ultrasound. I have a GI appointment today for further work up.

Should have started menstrual period anywhere from 3/18/21 to 3/22/2021, but did not get until 4/1/2021, which was 39 days from the previous period. Normally get them about 25 days apart. Then got it again on 4/19/2021. So it appears the vaccine gave me irregular periods, which I read has happened to others, so I am reporting it. Could be coincidence, but thought I should report anyway.

Symptoms include: vaginal spotting (blood) (not on period at the time), headache, urinary tract infection

Fever lasted two days, severe headache lasted two days, body aches lasted over a week, nausea is still present, fatigue is still present, arm soreness lasted a little over a week, dizziness is still present. Stabbing pains in my hands, feet and legs started a few days after the vaccine and my rheumatologist ordered ultrasounds on my legs, which showed no presence of clots. The pains lasted for about 12 days. Pain in my chest and breasts occurred yesterday and lasted about 2 minutes. Nipples are tender.

Immediately felt overwhelmed with heat and fainted (within 5 minutes) of receiving the shot. I was scheduled to have my normal period within a week and have never had another period. I am experiencing full on menopause and I have never had a single symptom. I have full sweats and freezing temperatures all throughout the day.

Patient has had menstrual bleeding for two weeks after the vaccination and then on random days have heavy and light bleeding .

I didn't feel anything in the beginning, when I came up that night, I found brown spots on underwear - I thought it was my period because I usually have period around that time. But then my period lasted two weeks every day (non stop) - too long (usually 3-5 days). I emailed my primary care doctor. April 15th - period became heavier; it lasted 3 or 4 days like and then it became less. I saw OB/GYN - she said it is almost stopped so she said my exam was normal. I still had my period two more days but then it stopped. In total, It lasted 2 1/2 weeks, it has never been that long before.

Heavy vaginal bleeding a day or so later. The bleeding was like a pouring out of blood so severe that it caused me to need a blood transfusion in the emergency room at hospital.

I got my vaccine while being on my minstrel cycle. My period lasted for 4weeks and it was very heavy. I experienced blood clots the size of a silver dollar. I had serve headaches.

COULD NOT SPEAK A FULL SENTENCE; VERY PAINFUL INFLAMMATION OF CHEST, INFLAMED CHEST WALLS; CRAZY RIDICULOUS VAGINAL BLEEDING; ANEMIC; ALMOST DIED; FAINTING AFTER BLOODWORK; CRYING FOR NO REASON; DOING REGULAR THINGS AT A SLOWER PACE; SLOWLY DYING; This spontaneous report received from a patient concerned a 47 year old, female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and expiry: UNKNOWN) dose was not reported, 1 total administered on 21-MAR-2021 for prophylactic vaccination. Concomitant medications included iron for anemia. On 21-MAR-2021, shortly after vaccination patient became very tired and felt like getting sick and felt like as it was the expected. Patient stayed on couch next day. On 23-MAR-2021, bleeding was started which was not normal bleeding. Patient knew that she had to see hematologist as oxygenated blood was leaving her body. Patient experienced very heavy vaginal bleeding. Patient called gynecologist and was advised to go to emergency room, if patient bleed more than a pad an hour. Patient went to doctor shortly because patient felt this was not normal and something else was going on. When doctor took patient's blood, she fainted. Patient was healthy before shot and never had this before. Patient had intravenous (IV) so that patient could drive home. Patient was doing regular things at slower pace. Some weird things happened at 17.00 daily, patient cried for no reason. Blood test was received with something low. Patient went to the emergency room where they gave her blood, which patient never needed before in her life. Patient needed 2 units of bloods. Patient was slowing dying but did not know it. Patient was now anemic and needed 4 iron infusions and maybe needed 5th also. Patient had been told to follow-up in august. Patient was not sure that her body was making her own blood again. Patient felt almost died. Patient could not speak a full sentence even after the emergency room visit. Patient was still bleeding. Patient also experienced inflammation in chest which was very painful. Patient started birth control on 14-MAY-2021 and 15-MAY-2021 and stayed on until 24-MAY-2021. Patient started bleeding again on 25-MAY-2021 which continued till 29-MAY-2021. Patient had a lot of shortness of breath and thought may be a blood clot but on 20-MAY-2021, X-ray showed no clots. Cardiologist said this was most likely from the COVID Shot and likely inflammation. Patient chest was still painful to touch and it was better than before. Patient was on iron pills but stopped after the 3rd infusion of iron and patient's anemia levels was improved. On 23-MAR-2021. Laboratory data included: Blood test (NR: not provided) showed low hematocrit and hemoglobin. Laboratory data (dates unspecified) included: Gynecological examination (NR: not provided) fine, and Physical examination (NR: not provided) fine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from crazy ridiculous vaginal bleeding on 29-MAY-2021, fainting after bloodwork on 09-APR-2021, and crying for no reason on 13-JUN-2021, was recovering from anemic, and could not speak a full sentence, had not recovered from very painful inflammation of chest, inflamed chest walls, and the outcome of almost died, slowly dying and doing regular things at a slower pace was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0: 20210651060- JANSSEN COVID-19 VACCINE Ad26.COV2.S –Fainting, Almost died, Vaginal bleeding, Anemia, Could not speak, Chest wall pain. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).

On May 9, I got the J&J/Janssen COVID vaccine at the local pharmacy in my neighborhood. On May 17, I got my period which was pretty much normal. Then on June 12, my period started as normal, however it didn't end until June 23. There was lots of heavy bleeding and tiredness. I haven't had a period for the month of July. It should have started around the 7th, but it's over a week late. I'm experiencing the bloating and tiredness of a period, except I'm not bleeding.

Menstrual cycle stoped for 2 months returning with a massive heavy flow. My cycles usually run 3 to 3 1/2 day and now I have a full 7 day cycle with extreme heavy flow! I also experience Brain fog along with muscles in fingers, thumb and arm twich intermittently.

Exactly one week after my shot, I have been experiencing the longest and worst period I have ever had. I did not connect the two at the time. But I now feel this was a reaction to the vaccination. I am passing blood clots, undergoing blood tests and having a ultrasound on my uterus because it is so out of the ordinary.

sore throat started at 4:00 pm, followed by severe chills and fever of over 101. Fever lasted for 24 hours. Muscle aches, extreme tiredness lasted for 5 days. spotting of period began 72 hours after vaccine and lasted 5 days. I have an iud and don?t typically spot or have menstrual flow.

Severe menstrual cramps/pain and Heavy period began abruptly 8 days early at 5:30am.. Previously every 28 days and light s/p endometrial ablation.

STARTED PERIODS X 2; THROBBING ARM (CARPAL TUNNEL AREA); STOMACH PAINS; CHILLS; TENDER BREASTS; EMOTIONAL; This spontaneous report received from a patient concerned a 48 year old female. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, and expiry: 13-JUN-2021) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced tender breasts. On 08-APR-2021, the subject experienced emotional. On 08-APR-2021, the subject experienced chills. On 09-APR-2021, the subject experienced stomach pains. On 10-APR-2021, the subject experienced started periods x 2. On 10-APR-2021, the subject experienced throbbing arm (carpal tunnel area). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from stomach pains on 12-APR-2021, and chills on 08-APR-2021, was recovering from tender breasts, and the outcome of emotional, throbbing arm (carpal tunnel area) and started periods x 2 was not reported. This report was non-serious.

Extremely heavy menstrual bleeding started thirteen days post vaccine and has not stopped (going on two weeks). This bleeding includes huge clots, some so large that they have to be ?pushed? out...some clots are the size of a small fist. The bleeding is consistent and has several episodes of gushing causing blood to overtake feminine hygiene products and spill all over clothing/furniture. During this bleeding clots can be felt passing as well even when seated. The clots have subsided somewhat compared to when this first started and bleeding appears to be slowing somewhat in the past day.

I have not gotten my period, which should have started April 9th (currently 20 days late). My breasts are extremely tender.

COMPLETELY UNRESPONSIVE; PROMINENT VEINS IN HANDS; WEAK; TIRED; COLD; SHIVERING; BEGAN A PERIOD THE DAY SHE GOT THE INJECTION, THEN IT STOPPED AD BEGAN AGAIN; This spontaneous report received from a consumer concerned a 48 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included menopause, and other pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021 about 10 hours after receiving the vaccine, the patient was cold and shivering (cold on the inside) and later became completely unresponsive, began a period the day she got the injection, then it stopped ad began again. At 1: 15 a.m. (date unspecified) she was sent to hospital. She received lab testing and imaging and she woke up within 5-6 hours. The results were inconclusive. On 11-APR-2021, the patient experienced feeling weak and tired, her veins were prominent in hands. She received unknown medication while in the hospital. She has not followed up with primary care physician nor has she been back to the hospital since. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from completely unresponsive, and cold and shivering on 11-APR-2021, and began a period the day she got the injection, then it stopped ad began again on 14-APR-2021, was recovering from weak and tired, and the outcome of prominent veins in hands was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0:-covid-19 vaccine ad26.cov2.s -completely unresponsive, began a period the day she got the injection, then it stopped ad began again. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).

Ten days after the shot I had intense stomach, groin, neck, and low back pain and I started the most painful period of my lifetime after being in menopause for one year. I bled profusely for six days. Still having random debilitating pain.

COVID-19 PNEUMONIA; ALLERGY TO VACCINE; STOOLS HARD; STOMACH SWELL UP; MUSCLE SPASMS/ CRAMPS; BREAST SWELLING; PAIN FROM BACK OF SPINE TO TOP OF THE HEAD; NUMBNESS IN THE FINGERS; ABDOMINAL TENDERNESS; BLANKED OUT; RINGING IN THE EAR; FACIAL SWELLING; PAINFUL BLISTER; DIFFICULTY EATING; This spontaneous report received from a patient concerned a 48 year old (Indian or Native/aboriginal) female. The patient's weight was 272 pounds, and height was 66 inches. The patient's past medical history included partial tubal ligation, and part of colon removed, and concurrent conditions included asthma, bronchitis, bleeding disorder (irregular period), cyst on ovary, gerd, high blood pressure, adhd, dysmenorrhea, tingling of extremities, asa allergy, narcotics allergy, soap residue allergy, lactose intolerance, tramadol allergy, sulfa antibiotics allergy, strawberry extract allergy, penicillin allergy, metronidazole allergy, nalbuphine allergy, oxybutynin allergy, bees wax allergy, haloperidol allergy, fluoxetine allergy, medroxy progesterone allergy, gabapentin allergy, and latex allergy. The patient had a blood test with her MD prior to and was told did not have Covid and could get the shot. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, expiry: unknown) dose was not reported, administered to right arm on 16-MAR-2021, around 16:00 for prophylactic vaccination. No concomitant medications were reported. The patient was treated with injections to prevent blood clots (they did injection in the stomach area). On 16-MAR-2021, around 09:00 PM, patient experienced facial swelling and blister on the right side of her lip was burst and formed a scab and that made it difficult to eat. On next morning, 17-MAR-2021, patient had excruciating pain from top of her head to nostrils, it caused being weak and blanked out. On the day after, 18-MAR-2021, patient had a different taste and a different smell, also had ringing in the ear and was nauseous. On the 5th day, 20-MAR-2021, patient's stomach was swelled and was really tender and breast was also swelled. The patient had a lot of headache, cramps, muscle spasms, body ache and was cold and hot. The patient had diarrhoea and had to lay down and had to crawl to bathroom with throwing up. The patient had high fever and could not keep anything down. On 20-MAR-2021, the patient experienced pain from back of spine to top of the head, numbness in the fingers. On 22-APR-2021, the patient experienced hard stools. On 27-MAR-2021, patient was hospitalized as she was coughing blood. On an unknown date, patient had patches on the x-ray and was diagnosed with pneumonia and her Covid (unknown) test was positive. Patient reported that she was given injections to prevent blood clots in the stomach area. The patient had pain back from spine to top of the head, was weak, had numbness in the fingers. She had headache, had lost appetite. The patient reported that as per her healthcare providers, was allergic to the vaccine as they noted shortness of breath, nausea and diarrhea. Laboratory data included: Body temperature (NR: not provided) High. On 27-MAR-2021, COVID-19 virus test positive (NR: not provided) positive, and X-ray (NR: not provided) blood patched, pneumonia. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from covid-19 pneumonia, and ringing in the ear, was recovering from facial swelling, painful blister, difficulty eating, stomach swell up, muscle spasms/ cramps, blanked out, and abdominal tenderness, had not recovered from pain from back of spine to top of the head, numbness in the fingers, and stools hard, and the outcome of allergy to vaccine and breast swelling was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0:20210507603-covid-19 vaccine ad26.cov2.s -covid-19 pneumonia. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: UNDERLYING DISEASE

charlie horses in legs in evening pain in lower legs mostly at night starting on or about 4/10, on 4/12 migraine and soreness in lower legs, Called urgent care, they said couldn't treat/check since no ultrasound machines, no primary doctor in this state so called and did virtual visit with dr from health insurance provider via telephone, determined to just wait to see what will happen since no pain in chest or lungs . 4/14 bad menstrual period, off cycle so associated migraine to hormone changes. leg pain continued especially at night for next several weeks. sore spots on legs but no heart or shortness of breath. pains during day and night in feet and legs some sore spots like a black and blue spot with no discoloration. on our about may 1/2 areas of hands by thumbs, feet, calf areas and upper arms getting like nerve pain just shooting pain feel like sparkler fireworks just burning under skin in certain sots them goes away. pain goes and comes at night in legs just really random now when things happen.

Irregular period (twice in one month) Diagnosed with shingles two days ago. Never had shingles before.

I had ablation completed and have been period free. the next month after the shot my periods started back up and have not stopped. I was also diagnosed with Sjogrens sydrome a month ago - not sure if it is related or not.

Despite being very regular, I skipped one cycle. I started two months late with 5 days of slimy thick blood, Then a very heavy flow that gushed out when I stood.

Chills, sweat, lethargic, headache, loss of appetite, sleepiness, back pain, menstruation (after none for 10+ years), body aches, hives

Chills, low grade temperature, headache, very tired, arm soreness for days, body aches, bloody nose(the day after vaccine I had pinkish discharge from left side of nose that lasted 8 days. On day 11 I had a bloody nose on right side that took approx 15 minutes to stop. Also starting day after vaccine, breast tenderness and fullness in both breasts..have had this everyday since and still have this.

Early onset of menstrual period with unusually heavy bleeding. I also had chills and fever within 24 hours of the vaccine and redness at the injection site.

The usual arm soreness and feeling of fatigue for a few days after. Not sure the following is related, but mentioning here due to the small number of women who experienced severe issues related to blood clots. Light nose bleeds - mostly when blowing nose - chunks - persists. Also, have been menopausal but am now having a cycle - thin and light bleeding.

4/13/21 - Day after, started fever, chills, tiredness for 36 hours 4/18/21 - Period started [2 weeks after last period]

10 days after the vaccine my menstrual cycle started 2 weeks earlier than expected. I am always regular and this has never happened before to me, Then, my regular cycle started again 2 weeks after. So I basically had 2 menstrual cycles in one month.

I?ve been experiencing unusual menstrual changes since I received my J&J dose on April 8th. A few weeks after the vaccine I was experiencing PMS symptoms (breast tenderness, hormone imbalance, breakouts, light cramping etc) and today I began what appears to be my first day. I was menopausal & my last period was December 2018. This is unusual.

8 hr post vaccine, typical side fx (fever, headache), but also significant bi-lateral leg cramping and spasms that continued for 6-8 hours. Spasms were prominent in inner thigh/groin and down entire legs. Legs were not movable (heavy), difficult to get out of bed or walk. Very strange and nothing like this ever experienced before shot. Fine next day. Around 4/9, pain began in ball of R foot in the AM, hard to walk. Over next few days, pain extended up to medial posterior calf (very painful), back of knee and groin. Unexplained bruising on lateral calf. 4/20 woke to swelling of R leg (ankle, posterior knee, groin), went to Urgent Care that night and was sent directly to ER for DVT symptoms. ER Ultrasound showed no clot, was sent home. Pain continued to increase, with burning and difficulty walking. Second Ultrasound done 4/22. No clots found. Pain continued to worsen, with swelling/aching on front of calf and severe foot pain. Veins/skin tender. Painful groin spasms happen again, same as night of shot. PCP ordered ABI and spine Xray. ABI was normal. Xray showed same issue as 29 yrs ago (prior known L5S1 anterolisthesis; have not had back pain for many years...when I did, it was localised to spine and sciatic in the L hip, was not at all similar to these current issues in R leg. perhaps related if inflammed, but is vastly different in symptoms and unlike past history). Saw Vascular Surgeon 4/30, ordered abdominal CT Abdomen Pelvis w IV Contrast. results normal. arm bruising at IV and blood draw site. Saw second Vascular Surgeon 5/4 who felt pain related to inflammation response and ordered CBC. Platelets 178. (patient had requested this test starting on 4/20, this was the first doctor to order it). Pain continued but some relief found with compression socks. on 5/10 US Bilateral lower extremity venous duplex with reflux study was done on both legs. No DVTs, but damaged valves and reflux in the external iliac common femoral vein and femoral veins proximal segment (worse in R leg) and great saphenous vein at the sapheno-femoral junction (R only). These areas are where the spasms are happening but doctor not able to conclude relation, wants neuro consult, could be nerves causing spasms. Doctor prescribed compression socks for venous insufficiency concerns, to be rescanned annually for life. Vascular test results don't explain severe pain in calf and foot and referred to Neurologist for 5/28 visit. As of today, 5/22, pain is persistent. Pain/swelling is reduced with use of compression socks but returns without them; walking is difficult in the AM and PM hours; night time spasms. Have also had shooting pains in L calf, both forearms, and ribs (back). These occur mostly in the evening (nerve?). Taking magnesium & extra vitamin D seems to help some. On strict anti-inflammatory diet. I'd really like some guidance for treatment and what to do about boosters - do I switch to an mRNA vaccine? I am a very healthy active 49 yr old woman who felt fine before the shot, and now I've been in a lot of pain, working greatly reduced hours for almost 4 weeks. Please advise on what can be done to help. Concerned about permanent damage and how to handle future vaccines. (also of note: first menstruation period was skipped after the shot, second period came a week late and was very heavy with bright red blood. I am normally extremely regular, mod-heavy flow; also, the J&J shot I had was a "last shot of the day" extra dose. I was offered it while having a routine physical. Could it have been improperly stored, as the last leftover dose? Very unlikely since it was a doctors office, but including this info)

I woke up at 02:00A with a bad headache, I took some Tylenol. On Thursday April 8th, 2021 around 02:00pm I had flu-like symptoms with body aches, fever, chills. The next day April 9th, 2021, I experienced fatigue, headaches and ringing in the ears. On the 4/10/2021, fatigue, headache and noise or ringing in the ears. On the 4/11/2021, fatigue, ringing in the ears. On 04/12/2021, dizzy spells which has continued. Feeling of lightheadedness and on the 04/14/2021 I went to see my doctor. Feeling of pressure in my ears with the ringing. For two weeks I struggled with the dizziness and lightheadedness. I also developed Tinnitus. I also had low back pain and pelvic pain.

It was really bizarre, I remember feeling like all my senses were heightened , I got my period, it didn't stop for 3 weeks. Called my OBGYN, they said let it run it's coarse and they had they had many similar phone calls. I take a Nuva ring for birth control, I was concerned about estrogen and the blood clots. I did not feel well at all for about a week after my vaccine, everyday around 4pm I would get really bad headaches for about 3-4 weeks. I was nauseated and sweating.

I wanted to report abnormal 16 day period following the vaccine, and now my next period is already 5 days late and I am experiencing pelvic and stomach pain that feels like a constant cramp and bloated feeling. I feel like the vaccine impacted my hormones in some way and now periods are unpredictable.

SWOLLEN LYMPH NODES UNDER HER ARMPIT; PAIN IN LEFT BREAST; KNOT IN BREAST; EXCRUCIATING BACK PAIN THAT COMES SHARPELY AND GOSE QUICKLY; ARM PAIN WHEN THE INJECTION SIDE HAS BEEN SQUEEZED OR PRESSED; This spontaneous report received from a patient concerned a 49 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A expiry: UNKNOWN) dose was not reported, administered on 04-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 04-MAY-2021, the subject experienced arm pain when the injection side has been squeezed or pressed. On 14-JUN-2021, the subject experienced excruciating back pain that comes sharpely and gose quickly. On an unspecified date, the subject experienced swollen lymph nodes under her armpit, pain in left breast, and knot in breast. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from arm pain when the injection side has been squeezed or pressed, swollen lymph nodes under her armpit, pain in left breast, excruciating back pain that comes sharpely and gose quickly, and knot in breast. This report was non-serious.

SEVERE INFLAMMATION; WEAK RIGHT LEG; ANXIETY; SEVERE HEADACHES/ "BUBBLES" GOING UP THE BACK OF THE HEAD; SHOOTING PAIN IN FOREARM; NAUSEA; VALVES DAMAGED (SAME AREAS WHERE THE SPASMS WERE OCCURRING); NERVE PAIN; HARD TIME SLEEPING; SKIN HURT TO TOUCH (SENSATION OF BUGS CRAWLING UP THE LEG).; 4-5 BRUISES FROM CALF TO ANKLE THAT DID NOT LINE UP WITH THE PAIN.; SWELLING AROUND THE ANKLE, KNEE AND GROIN (ALL IN THE RIGHT LEG); PAIN AND CRAMPING IN CALF; DIFFICULT TO GET OUT OF THE BED (DUE TO THE SPAMS AND THE FEELING IN HER LEGS); LEGS FELT LIKE WEIGHED 500 LBS (NOT PAINFULL); STRANGE SPAMS LIKE FULL BODY TREMORED (CONCENTRATED IN THE LEGS AND GROIN)/ SPASM IN BOTH LEGS; NUMBNESS IN FOOT; SWELLING IN LEG; BURNING SENSATION; IRREGULAR MENSTRUAL CYCLE (NO SIGNS OF MENOPAUSE); EXTRA DOSE; CHILLS; ICKY; SMALL PATCH OF PAIN OF THE FOOT PAD TOWARDS THE OUTSIDE OF THE FOOT/ SORE ARM/ PAIN IN ARM/ AREA OF PAIN GOT BIGGER; FEVER; TIRED; This spontaneous report received from a patient concerned a 49 year old female. The patient's weight was 115 pounds, and height was 62 inches. The patient's past medical history included spinal injury, and left sided sciatica pain, and concurrent conditions included non-smoker, gluten allergy, and alcohol user (occasionally (1 drink/day)), and other pre-existing medical conditions included the patient had no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A421A expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 31-MAR-2021, the subject experienced irregular menstrual cycle (no signs of menopause). On 31-MAR-2021, the subject experienced extra dose. On 31-MAR-2021, the subject experienced chills. On 31-MAR-2021, the subject experienced icky. On 31-MAR-2021, the subject experienced small patch of pain of the foot pad towards the outside of the foot/ sore arm/ pain in arm/ area of pain got bigger. On 31-MAR-2021, the subject experienced fever. On 31-MAR-2021, the subject experienced tired. On APR-2021, the subject experienced swelling in leg. On APR-2021, the subject experienced burning sensation. On 01-APR-2021, the subject experienced strange spams like full body tremored (concentrated in the legs and groin) / spasm in both legs. On 01-APR-2021, the subject experienced numbness in foot. On 01-APR-2021, the subject experienced difficult to get out of the bed (due to the spams and the feeling in her legs). On 01-APR-2021, the subject experienced legs felt like weighed 500 lbs (not painfull). On 11-APR-2021, the subject experienced pain and cramping in calf. On 20-APR-2021, the subject experienced 4-5 bruises from calf to ankle that did not line up with the pain. On 20-APR-2021, the subject experienced swelling around the ankle, knee and groin (all in the right leg). On 20-APR-2021, the subject experienced skin hurt to touch (sensation of bugs crawling up the leg). Laboratory data included: Diagnostic ultrasound (NR: not provided) Didn't find a clot. On 23-APR-2021, Laboratory data included: Diagnostic ultrasound (NR: not provided) Negative. On 29-APR-2021, the subject experienced hard time sleeping. On 30-APR-2021, Laboratory data included: Ankle brachial index (NR: not provided) all clear, Computerized tomogram pelvis and abdomen (NR: not provided) all clear, and Spine X-ray (NR: not provided) all clear. On MAY-2021, the subject experienced valves damaged (same areas where the spasms were occurring). On MAY-2021, the subject experienced nerve pain. Laboratory data included: Cardiac ultrasound (NR: not provided) valvular damage coinciding with pain on legs. On 04-MAY-2021, Laboratory data included: CBC (NR: not provided) all normal, Platelet count (NR: not provided) 178 (lower than her normal), and Protein (NR: not provided) Result not reported. On JUN-2021, the subject experienced nausea. On an unspecified date, the subject experienced shooting pain in forearm, severe inflammation, anxiety, weak right leg, and severe headaches/ "bubbles" going up the back of the head. Laboratory data (dates unspecified) included: Reflex test (NR: not provided) result not reported, Right leg was weaker. Treatment medications (dates unspecified) included: ibuprofen, magnesium, acetylsalicylic acid, paracetamol, tocopheryl acetate, and ergocalciferol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from strange spams like full body tremored (concentrated in the legs and groin)/ spasm in both legs, burning sensation, chills, fever, and tired, irregular menstrual cycle (no signs of menopause) on 31-MAR-2021, and difficult to get out of the bed (due to the spams and the feeling in her legs), and legs felt like weighed 500 lbs (not painfull) on 01-APR-2021, was recovering from small patch of pain of the foot pad towards the outside of the foot/ sore arm/ pain in arm/ area of pain got bigger, severe headaches/ "bubbles" going up the back of the head, numbness in foot, pain and cramping in calf, 4-5 bruises from calf to ankle that did not line up with the pain., weak right leg, nausea, icky, extra dose, swelling in leg, swelling around the ankle, knee and groin (all in the right leg), skin hurt to touch (sensation of bugs crawling up the leg)., hard time sleeping, severe inflammation, valves damaged (same areas where the spasms were occurring), nerve pain, and anxiety, and had not recovered from shooting pain in forearm. This report was non-serious.

Day one: pain in arm, extreme fatigue, nausea, fever, blurred vision, heavy chest, headache, eye burning pain, pain in side of neck and intonarmoit, pain in right calf, runny nose, burning in nose and throat, oversensitive to touch like clothes Day 2: runny nose, fatigue. congestion, headache, injection site pain Day 3: scratchy throat, watery eyes, arm sore at infection site, naseua, low energy Over the next four days symptoms lessened. At day seven finally felt back to normal. Day 18 &19- spotting blood, period is 9 days early which is not normal. I'm never this early or irregular

3/18/2021 approximately at 9pm it started with a headache, nausea, fatigue. All symptoms except the headache resolved. headache continued intermittently until present date. New symptom occurred (3/20/2021)2 days after vaccine, this menstral cycle was one week early and lasted 2.5 weeks with mild abdominal pain. Mensuration ended on 4/12/2021 with mild abdominal pain persistent to present date.

The night of the vaccination (3/8), my body felt very hot (not fever) like it was going to catch on fire. I took Tylenol to be safe and went to bed taking it as a sign that the vaccine was working. I thought I was mostly over the next day, but four days later on 3/12, I started bleeding only two weeks after my last period, and the it was quite different than usual - very fresh blood and lots of it. This continued for 15 days at time with very heavy flow - I bleed non-stop, and I worried that I was going to bleed to death. The worst adverse effect happened 10 days after the vaccination on 3/18. Out of blue without anything unusual, I started feeling very dizzy, nausea, and vomiting. After much vomiting, nausea stopped, but the dizziness just got so bad, I couldn't move or even keep my eyes open (things were spinning even with my eyes closed). I couldn't even stand up by myself. This most horrible severe vertigo lasted two and got gradually better. It took about 5 days before I felt safe enough to be alone by myself. During this time, I had a excruciating headache on my left side. It was so bad, I quickly took some painkillers which knock me out for a day. The important thing is that I don't ever get headaches; this is the first one I had aside from one I had when going through IVF more than a decade ago.

She started to have heavy vaginal bleeding. On 04/14/2021 she started to have back pain that radiated to the left leg and anterior abdomen.

I have not had a period or any period related symptoms for 13 months and had considered myself, by definition to be in Menopause. 13 days after the vaccine I started having lower back pain, cramps and headaches. I didn't know what it was as I hadn't considered it to be PMS. The next day, day 14 post vaccine, I got my period and ended up in bed with lower back pain, heavier than previous bleeding and headaches. Today, is day five of the menstrual bleeding. While the bleeding is lessening, the cramps and headaches are not. This is not typical for me based on my recollection of PMS/MS. I am concerned that the cramping and headaches have not subsided and I am concerned as to why I am having a period after 13 consecutive months of nothing.

High fever (102/103), chills, severe muscle aches, splitting migraine headache. A week later I had my period and experienced heavy bleeding and passing large blood clots not normal to my usual period. Still having headaches and its been 3 weeks.

I had two menstrual cycles in quick succession with spotting in between. The first started on 4/9 and was not out of the ordinary except that spotting continued, then a second started on 4/22. I would normally have cycles no sooner than 21 days apart.

Abnormal menstrual experiences. Bleeding between periods, 4/5 and 4/9. Heavy, lengthy period 4/18-27.

Pt had light menstrual cycle then spotting for many weeks then a consistent cycle for 10 days. Pt previously very regular.

Burning at injection site. Headaches. I was in menopause and now I have had two periods with heavy flow since the shot.

Person who administered hit a nerve, headache, dizziness, nausea, and a metal taste in my mouth. After 45 minutes. resting heart rate jumped to 140 and normally 70, after 45 minutes, it went down to 130 and I had my husband take me to the car. After 10 days I continued heachache, ear ache, extreme fatigue, nausea, my resting heart rate was still at 130 it would not go down, I had swollen lymph nodes under both arms. On the 10th day i called the doctor and went to ER my left leg began swelling up and I had extreme pain from my hip all the way down to my ankle. and plus all the prior symptoms. The doctor did a vein ulta sound didn't find anything. The doctor laughed at me like I was crazy. I have high pain tolerance and I was in extreme pain. And the doctor did not take me seriously. I followed up with the physician the next day. and asked her to report it, but as far as I know she didn't report it. I just started feeling better, May 20 th, from april 6. for me to start feeling normal again. I'm starting menopause, and I had not had my period since November 2019, And after I received the vaccine, I started my period , twice a month. my hormones are messed up and I have to take a nap in the afternoon from feeling fatigue.

Menstration started the next day, May 11 and has continued as of this date, May 27th. It is accompanied with bloating, cramping, bright red blood, spotting, and clots. This is not normal for my cycle.

My normal menstrual period of 5-6 days lasted over 22 days. 16 days longer than normal. This has never happened before. I contacted my doctor but did not have any in person appointments.

Post menopausal woman. Period began again day after shot. 4 weeks later heavy period with bleeding soaking pads every hour with thick clots. Also experienced allergic reaction at time of injection. Swelling of lips and difficulty breathing. Took Benedryl.

Hot flashes. Started suddenly, having zero before to having about one every hour or so, both day and night. Each one would last about 10-15 minutes. My temperature increased 2-3 degrees (from 96 to 99). As suddenly as the they started, they stopped on June 9, roughly. Also period went from regular to nothing during this time and it hasn?t returned even though hot flashes have subsided.

I've had frozen shoulder and nerve tingling that has continued. Also, my first period after the vaccine went on for 9 days. The second period was 6 days-regular for me- however, there was a huge clot the span of 5 quarters that was about 3/4 an inch thick.

I had a very heavy period starting on the 6th and it was clotting, it was overly heavy. That continued about a week and stayed heavy. I also started getting hot flashes every five minutes and those would come and go all day long. I was dripping all day long. Those lasted a week about a week too and then they were done and I haven't had any more. I had a full physical before I took a trip and I told my doctor about these symptoms. I didn't have another period until May 26th which was a normal one and on that same day, my breasts swelled super big. Almost double the size. On the 27th of May, I went to the doctor. He ordered a mammogram and an ultrasound. That was on the June 2nd. I had those done at the hospital They found huge cysts, one was five inches long, on my breasts, (both) full of them all of a sudden. About a week later, those cysts went away and everything was fine. My breasts went down to normal size.

Day 1-7: Headache, fatigue, dizziness, tinnitus, severe cramping in feet, foot pain, menorrhagia Day 8: Syncope, lightheadedness, tinnitus, numbness and tingling in left foot and left hand, metrohaggia Day 8-30: Headache, dizziness, tinnitus, left foot swelling, foot pain, numbness and tingling in left hand and foot, polymenorrhagia Day 26-27: Epistaxis, headache, fatigue, dizziness Day 28: CT scan detected layering fluid in the posterior left ethmoid air cell

On April 9th 2021, 2 days after being vaccinated with J&J, I got my period. Very heavy flow. I am almost 52 and haven't had a period since 10/27/20. I also historically have not had heavy periods. I alerted my Dr today in an online note form about this as I find it odd and very unexpected. I have had fatigue but otherwise no additional adverse events.

Pain, swelling, redness, and hot to touch at injection site from the time of administration of vaccine that persisted for almost 3 weeks. Around 6:00pm the same day I received vaccine, I started getting chills and strong aches in my back and legs. I felt very dizzy, lightheaded and sleepy. Chills were gone by the next morning, but aches and sleepiness continued for 4 days. Dizziness and lightheadedness continues til now. A little over a week after vaccination, I had random bruising on my legs on the same side I received vaccine. My lymph nodes were visibly swollen and my breasts felt extremely tender. Bruises are still healing, but lymph nodes and breasts seem relatively normal now, exactly 3 weeks after initial vaccination

I was on my period when I received the shot. It lasted one week and was very heavy. In 8 days I started another period which lasted 7 days. 5 days later I just started my period again. It's been less than one month and I've had 3 periods which is completely abnormal for me. I also have just recently read about the severe blood clotting happening in women and deaths related to this vaccine. I'm very concerned and have an appointment with my doctor on 3/19 to check my blood platelets.

Started having a period after not having one for 4 months. Tightness, slight pain in groin on right side. 3 small bruises in a line on right leg.

I didnt have a menstrual period since November of 2020. I received my vaccination and woke up in the middle of the night to my period. I keep hearing that the vaccine doesn't have any affect on menstruation but I find it hard to believe this is a coincidence.

End of menopause hot flashes days after dose and return on menstrual cycle after 8 months, cycle to date has been 25 days in length and heavy

On May 12th I started menstrual bleeding that lasted for about a week that was quite heavy for a couple of days and was similar to a regular period except that I am in menopause and have not had a period for about 3 years

FELT LIKE IMMUNE SYSTEM TAXED; COLD SORE; LARGE SCABS ON NOSE; TIRED; EXTREMELY HEAVY PERIOD; DIARRHEA/ STOOL WAS LIQUID; CLAMMINESS; SHORTNESS OF BREATH; FEVER; STOMACH PAIN; NAUSEA; AREA BELOW EYES ALL THE WAY DOWN TO HER CHEST BECAME NUMB; GENERALLY UNWELL; HEART SLOWED DOWN; EXTREME DROWSINESS; SPEECH SLOWED DOWN; ITCHINESS SPREAD TO THE ENTIRE BODY/ ITCHINESS IN HER EYES AND NOSE; NIGHT SWEATS; WEIRD DREAMS; This spontaneous report received from a patient concerned a 51 year old female. The patient's weight was 175 pounds, and height was 69 inches. The patient's concurrent conditions included allergic to cats, allergic to pollen, alcohol use, and cigarette smoker, and other pre-existing medical conditions included the patient had no drug abuse or illicit drug usage. the patient was healthy and not pregnant at the time of the reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, expiry: UNKNOWN) dose was not reported, administered on 06-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-MAY-2021, the subject experienced heart slowed down. On 06-MAY-2021, the subject experienced extreme drowsiness. On 06-MAY-2021, the subject experienced speech slowed down. On 06-MAY-2021, the subject experienced itchiness spread to the entire body/ itchiness in her eyes and nose. On 06-MAY-2021, the subject experienced night sweats. On 06-MAY-2021, the subject experienced weird dreams. On 06-MAY-2021, the subject experienced area below eyes all the way down to her chest became numb. On 06-MAY-2021, the subject experienced generally unwell. On 07-MAY-2021, the subject experienced stomach pain. On 07-MAY-2021, the subject experienced nausea. On 07-MAY-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 101-102 F, and Pain scale (NR: not provided) 8/10 (unit not reported). On 10-MAY-2021, the subject experienced clamminess. On 10-MAY-2021, the subject experienced shortness of breath. On 10-MAY-2021, the subject experienced diarrhea/ stool was liquid. Laboratory data included: Body temperature (NR: not provided) 99 -100 F. On 11-MAY-2021, the subject experienced extremely heavy period. On 12-MAY-2021, the subject experienced tired. On 03-JUN-2021, the subject experienced cold sore. On 03-JUN-2021, the subject experienced large scabs on nose. On an unspecified date, the subject experienced felt like immune system taxed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from extreme drowsiness, and area below eyes all the way down to her chest became numb on 06-MAY-2021, itchiness spread to the entire body/ itchiness in her eyes and nose on 07-MAY-2021, weird dreams, and diarrhea/ stool was liquid on 14-MAY-2021, stomach pain on 08-MAY-2021, clamminess, shortness of breath, and nausea on 12-MAY-2021, and tired on 17-MAY-2021, was recovering from fever, cold sore, large scabs on nose, and felt like immune system taxed, had not recovered from night sweats, and generally unwell, and the outcome of extremely heavy period, heart slowed down and speech slowed down was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required per standard procedure as the case assessed as non-serious.

PERIOD NOT AS HEAVY AS NORMAL; SPOTTING CONTINUED FOR 3 WEEKS; LOW BODY TEMPERATURE; DOES NOT FEEL NORMAL OR RIGHT; SWELLING IN LEGS AND FEET; DID NOT FEEL GREAT; FELT FEVERISH; HEAVY MENSTRUAL BLEEDING FOR 2.5 WEEKS; WATER RETENTION IN LEGS AND FEET DAILY; WEIRD BLOATING; PERIOD (BLOOD VOLUME) UP AND DOWN; 28 TO 30-DAY CYCLE ERRATIC, PERIOD WOULD START AND STOP AND MONTHLY CYCLES THROWN OFF; DID NOT HAVE A PERIOD AND PERIOD STOPPED; ANAPHYLAXIS REACTION; HEAD AND NECK NUMB; IV INFILTRATED; RED ARM; SWOLLEN ARM; FATIGUE; This spontaneous report received from a patient concerned a 51 year old white female of not hispanic or latino ethnicity. The patient's weight was 179 pounds, and height was 64 inches. The patient's past medical history included 28 to 30-day menstruation cycles with heavy bleeding for the first 4 days then tapers off, water retention, and swelling, and concurrent conditions included daily over the conter medication allergy, allergy related to asthma, flu shot has similar sore arm, bees allergy, dust mites allergy, cats allergy, dogs allergy, alcohol drinker (occasionally, special occasions, 2 per month), and non smoker, and other pre-existing medical conditions included patient had no menstruation changes since 13 years. patient was uses medications prn and patient had no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: UNKNOWN) dose was not reported, 1 total administered on 10-APR-2021 to right arm for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the patient experienced anaphylaxis reaction. Before the needle got out of the patient's arm the patient experienced hives on wrist and arm on the same arm used for vaccination after that the patient's throat began to close. On the same day the patient head and neck numb. Patient further described that it was not numbness but rather the blocked of oxygen due to her throat swelling. Soon after patient was taken to the emergency room through ambulance and treated her with diphenhydramine hydrochloride, epinephrine, and prednisone. Patient experienced iv infiltrated while in the ambulance ride. Patient remained in the emergency room for the protocol specified number of hours for monitoring. Patient had electrocardiogram (NR: not provided) Normal. Patient got released from hospital the same day when stable and normalized. On10-APR-2021, the patient experienced common vaccine reaction of a red and swollen arm, the patient did not have a period and period stopped and patient experienced fatigue. On MAY-2021, the patient experienced 28 to 30-day cycle erratic and period would start and stop and monthly cycles thrown off. On JUN-2021, the patient experienced spotting, water retention in legs and feet daily, weird bloating and period (blood volume) up and down. On JUL-2021, the patient experienced heavy menstrual bleeding for 2.5 weeks. On an unspecified date, the patient experienced low body temperature. period not as heavy as normal, spotting continued for 3 weeks, more menstrual bleeding, extensive time frame for period, does not feel normal or right, swelling in legs and feet, did not feel great, and felt feverish. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) Low. Additional treatment medications (dates unspecified) included: hyetellose. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from anaphylaxis reaction, and head and neck numb on 10-APR-2021, period not as heavy as normal, and weird bloating, and fatigue, and felt feverish on 21-JUN-2021, was recovering from did not have a period and period stopped, 28 to 30-day cycle erratic, period would start and stop and monthly cycles thrown off, water retention in legs and feet daily, and swelling in legs and feet, had not recovered from spotting continued for 3 weeks, and period (blood volume) up and down, and the outcome of iv infiltrated, red arm, did not feel great, low body temperature, heavy menstrual bleeding for 2.5 weeks, does not feel normal or right and swollen arm was not reported. This report was serious (Life Threatening). This case, from the same reporter is linked to 20210757746. .; Sender's Comments: V0: 20210745140- Covid-19 vaccine ad26.cov2.s-Anaphylaxis reaction. This event(s) is labeled per RSI and is therefore considered potentially related.

I am in menopause and not had a menses in over 10 months. My vaccination was around 12pm on Thursday, March 11, 2021 and Friday evening, around 8pm, I began to spot and the next few days to present, continue to have a period. Hopefully will be over within a few days. Since this in not listed as possible side effect I wanted to report especially in light of the inflammation women are experiencing with mammograms. I know two other women in same situation but with Moderna. Clearly, the vaccine is effecting female hormones (estrogen, progesterone or FSH, lutenizing hormone). I'm still happy to have the vaccine and advocate for it.

1. Immediately following vaccination, pain at injections site, lasted 72 hours. 2. Twelve hours after vaccination - fatigue and muscle stiffness soreness in the lower back and legs, duration 12 hours. 3. Five days post vaccination, delayed onset of menstrual cycle. Spotting for 4 days when period was due. Severe cramps - unusual - waking up with pain and requiring pain relievers. Period began 5 days late. 4. Seven days post vaccination - chest tightness, with burning. Difficulty taking a deep breathe. Forced coughing while attempting to take a deep breath. This symptom is still persisting after nine days.

LEFT-SIDED TORSO PAIN; FATIGUE; LEFT BREAST PAIN; RASH INFERIOR LEFT BREAST; LEFT BREAST REDNESS; LEFT BREAST INFLAMMATION; INJECTION SITE PAIN; SWELLING OF LEFT BREAST; This spontaneous report received from a patient concerned a 52 year old female. The patient's weight was 126 pounds, and height was 57 inches. The patient's concurrent conditions included non smoker, and non alcohol user, and other pre-existing medical conditions included the patient had no known drug allergies. the patient did not have ant drug abuse or illicit drug usage.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced swelling of left breast. On 09-APR-2021, the subject experienced injection site pain. On 17-APR-2021, the subject experienced left breast redness. On 17-APR-2021, the subject experienced left breast inflammation. On 17-APR-2021, the subject experienced left breast pain. On 17-APR-2021, the subject experienced rash inferior left breast. On 19-APR-2021, the subject experienced left-sided torso pain. On 19-APR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from injection site pain on 16-APR-2021, had not recovered from left-sided torso pain, left breast redness, left breast inflammation, fatigue, left breast pain, and rash inferior left breast, and the outcome of swelling of left breast was not reported. This report was non-serious.

First couple days: Headache, Fever, body aches, fatigue First week after initial couple days: headache, fatigue for three weeks: fatigue ENTIRE TIME: HOT FLASHES I should have gotten my period the weekend after the sht. As of today I still have not gotten it.

Experienced two menstrual periods for April; one as expected starting on 19th and another which started on 29th. Both had heavier blood flow than usual.

My period is very regular, every 28-29 days. It always has been. I had a period start on 4/1/21, then totally missed a period that should have started 4/29/21, then I started one on 5/30/21 and I have been bleeding for 16 days straight. It is very heavy, and I am passing big clots. It looks like a tablespoon (or sometimes bigger) and it looks like dark red jelly. I can feel it moving before it plops out. I haven't experienced this type of clots since I first had babies (since more than 26 years ago.)

I had an auto-immune flare up starting the day after the vaccine. I took care of myself. Then over the course of the next couple of weeks. I had on and off headaches. My thyroid then in April 2021 - it swelled (I had another auto-immune flare up). My neck gets really thick feeling and kind of swollen. In May, on and off, I had symptoms of my legs falling asleep more often. My vision has gotten worse in the last three months. It is a little more blurry. I had a lot of breast tenderness happen. I went for a mammogram. My anxiety and depression is off the charts and I'm able to manage things pretty well usually. I talked to someone this morning and a therapist, too. Thinking what to do given insurance. I had been discounting the symptoms because I was not thinking it was vaccine. It has increased a lot in the last three months, though, all the doctoring and symptoms I have had. I've felt out of whack; exhausted a lot and have put on a lot of weight. It's still all happening.

Since the shot, I have very hard swelling in the lower legs, with a red bumpy rash and little blisters on the front of my calves. It burns and is the worst in the mornings when I wake up. It is extremely tender to the touch. I also have a hardness in the lower legs. The other issue I started experiencing is a one day menstrual period every week since the shot. Thirdly, I have an odd peanut size bump on my left hand middle finger right under the nail that is squishy.

after receiving shot, I waited 30 min, because I had bells palsy in the past (about 16 years ago) it was an extra pre caution, approximately an hour later I felt slight dizziness which was not a concern for me and passed quickly. approx 2 or so hours later i got a bad stomach cramp similar to a bad menstral cramp however I am menopausal so this was unusual. I believe it happened 2 or 3 times, that afternoon and maybe once the following day but never again. The next day after my vaccine 04/04 I experienced a very low fever, came and went most bothersome was the chill and tiredness i felt by evening, by 04/05 every symptom was gone just a bit of sore arm. I was away on vacation when I heard the news about the pause and was concerned because I had stomach cramps . These cramps were just after the shot and came and went quickly so maybe not much of an issue. Upon return from my vacation last night, I blew my nose and there was blood in my right nostril. it was not a flowing blood and I think it may have just been caused by the dry air in the airplane? it was approximately 5.5 hr flight. Maybe not related but thought I would mention it.

4/11/2021 830PM I NOTICED MOISTURE IN MY UNDERWEAR. WENT INTO BATHROOM , PANTIES BLOODIED, BRIGHT RED AND A QUARTER SIZED CLOT WAS INTHE TOILET. I SUFFERED NO PAIN. HOWEVER I HAD A TOTAL HYSTERECTOMY IN 1997, AND SHOULD NOT HAVE ANY BLEEDING WHATSO EVER. TOOK A SHOWER, ADVISED MY HUSBAND OF THE INCIDENT. WENT TO BED , 230AM 4/12/2021 SAME THING HAPPENS, ONLY NOW I AM WIPING BRIGHT RED BLOOD AND I FELT A LARGER SIZED CLOT LEAVE MY BODY. I WENT TO THE ER IMMEDIATELY.

My first menstrual cycle after the shot (03/12)2021); I had the worst cramps ever ( I never cramp) my flow was super heavy, I was going through pads and tampons at least every two hours. The second menstrual 04/14/2021) cycle I had a heavier than usual flow, not as heavy as the March cycle, but no cramping. The first flow was so unusual and the cramps were so bad that I contemplated going to the emergency room. While searching google I read an article that said unusual menstrual cycles was on of the side affects of J&J Covid Vaccines

I am on menopausal replacement estrogen and take progesterone a few times a year to force a "period". While on progesterone I dont have bleeding until I stop the progesterone I got the shot and had my period while ON the. progesterone.. Usually because I am menopausal I have 2 days of light panty liner bleeding. I was taking my progesterone (May 18-may 28) and got the vaccine on May 21. By May 25th I started a heavy period with significant bleeding and clotting. The heaviest period I ever remember in my life. It was heavy flowing . while in the shower or on the toilet. Very strange never experienced anything like it before. other symptoms cramping etc were normal level based on the bleeding. Day #6 still have some bleeding but mostly over at this time. As a pharmacist I am aware of other possible clotting disorders so I am watching and looking for other adverse events within the next few weeks to assure I have no other problems. So far besides exhaustion it seems like the vaginal/endometrial bleeding is the only issue.

Severe headaches beginning next day after vaccine last one month, also post menopausal bleeding 3 weeks after the vaccine lasting several days. Went to OB/Gyn provider for a uterine, vaginal and pelvic ultrasound with no etiology for bleeding.

I received the Jannsen Covid Vaccine on April 05, 2021 at 08:50 am. On April 09,2021 at around 04:30 am I woke up with vaginal spotting. I had a full hysterectomy in 1999, 21 years ago. Alarmed. I took myself to urgent care. I was tested for a Urinary Tract Infection and a Yeast Infection by pelvic examination. Both tests were NEGATIVE. I was prescribed Diflucan 2 doses 150mg each to take 3 days apart. I discontinued the Diflucan upon learning of the negative result for yeast. April 10, 2021 I was still experiencing Vaginal bleeding upon waking up. April 11, 2021 the spotting had ceased.

abdominal pain associated with MORE vaginal bleeding 1day after vaccine (pt already had vaginal bleeding preceding vaccine)

Left breast pain and tenderness as well as a pulling sensation that was painful. This started approximately 10 days after the shot and are now subsiding seven weeks after the injection. I want to my oncologist who then sent me for mammogram and ultrasound to check for cancer. All those tests came back negative.

Later that night she could not walk, had chills, had fever, and couldn't sleep and eat for two days, went to family doctor Dr. still couldn't figure out what was going on still was having problems breathing and leg was having terrible shivering and is also having menstrual problems that she hasn't had in years; she also stated that she is having a hard time with moving .

I am 54 years old and have not had a period in the last 6 years I just started my period 2 days ago. My whole body has felt inflamed since I received the vaccine and now I'm having a period

On the 11th, I started having pain in my breast, I kinda just left the pain for a week and it wasn't going away I also started spotting, I have been menopausal since mid 2018, Heavy bleeding started on May 8 to the 11th. The biggest problem is with my breast , they are swollen, under my breast are purple and red. I started to get chills, nausea, I could not wear a bra. The doctor treated it as mastitis, I was on two different antibiotics, nothing has helped it, I'm having to see a breast surgeon. no one knows what this is and they are not sure.

Day 1- Excruciating bone pain in ribs, pelvis, and shins that felt like drill holes. My back felt shattered. Muscles seized up and vein throbbed from inflammation. Lymph nodes swollen and throat was slightly raw. Could choke on water. Body temperature dropped, not chills, but icy cold. Took sleeping pills at 11 pm and never slept from the pain. Started dosing with turmeric and alka seltzer to douse the acidity inside body. Then did ibuprofen at 5 am not able to have BM Day 2- Tiredness, Broken vessels behind right knee that weren?t there before. Abdominal cramping in the uterus area. Still had bone pain. Restless leg symptoms. Not able to have BM Day 3 - a cough has started but only bone pain is In shin.

4 hrs after onset of severe headache and body pain in lymph nodes under arm pit breast, on top of kidneys and in stomach fatigue low fever. After 4 days of that I got a really super heavy period with cramping and blood clots in my menustral flow. It was a horrible period, while the one after the surgery in Feb was very light. Dizzy and fatique 10 days after shot on the April 8 I took a fall from a chair outside, and from Thrusday to the Saturday 10th I ended up in the Emergency room with a concussion and head symptoms including dizziness and nose bleeds. This was from a simple fall, and i suspect the covid shot might have caused complications after the fall with additional swelling and brusing.

4 days after the shot I got my periods. It lasted 4 days. That's not normal for me. It was a full, regular periods, not spotting. I haven't had my periods in a long time, as I am menauposed. My OBG doctor wants to perform a endometrial biopsy on April 26.

POST MENOPAUSAL BLEEDING; ITCHING ON TONGUE AND WHOLE INSIDE OF MOUTH; BURNING ON TONGUE AND WHOLE INSIDE OF MOUTH; This spontaneous report received from a patient concerned a 55-year-old female. The patient's weight was 112 pounds, and height was 62 inches. The patient's concurrent conditions included Crohn's disease, and irritable bowel syndrome. The patient was a non-alcohol user and nonsmoker. The patient had no history of drug abuse or illicit drug usage. The patient experienced drug allergy when treated with ampicillin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, and expiry: UNKNOWN) dose was not reported, administered, 1 total, to right arm on 08-MAR-2021 for prophylactic vaccination. Concomitant medications included fluoxetine hydrochloride for irritable bowel syndrome. After vaccination on 08-MAR-2021, the patient experienced itching and burning on tongue and whole inside of mouth. On 11-MAR-2021, 3 days after vaccination the patient experienced post-menopausal bleeding and had not bleed in 4 years and bled 3 days after the vaccine and bled for 7 days (like a heavy period). The patient went to gynecologist on 25-MAR-2021 and got a vaginal exam and internal ultrasound and was normal per physician. The physician recommended dilatation and curettage and this had not been as of yet. On 25-MAR-2021, Laboratory data included: Diagnostic ultrasound (NR: not provided) normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from post menopausal bleeding on 18-MAR-2021, and had not recovered from itching on tongue and whole inside of mouth, and burning on tongue and whole inside of mouth. This report was serious (Other Medically Important Condition).; Sender's Comments: V0. 20210435799-covid-19 vaccine ad26.cov2-Post menopausal bleeding. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).

Patient is post menopausal and has not experienced vaginal bleeding for years. She experienced vaginal bleeding beginning about 9 days after being vaccinated.

Restarted Menses (menopause for 2yrs prior), reversal of hair from gray to black by root, increase in energy, restless, can't sleep.

Couple of hours after the vaccine I got a fever I had a fever on 3/13/2021 & 3/14/2021. I've been through menopause & on 3/15/2021 I got my period after 18 month not getting it. It lasted for 5 days. I seen my on 3/16/2021 and she did an internal exam & she did say it appeared to be a regular period & she ordered additional tests.

Patient received the vaccine on march 17, 2021. Today while talking on the phone with her today she mentioned that she started her period after getting the vaccine, March 20, 2021 and still has it as of today. She hasn't had a period since she was 47 and started menopause. She is 56 years old.

Menstrual cycle. I've been in menopause since I was 47. I'm now 56. Bleeding started 3 days after the injection. I'm still bleeding, today is April 22. My obgyn did an ultrasound and said the lining of my uterus has thickened and she conducted an in office "mini" D&C for a biopsy. From those results, my progesterone dose was doubled.

Day 2: severe headache, joint and muscle pain, extreme fatigue. Day 3: in addition to the first symptoms a red raised rash on neck, torso , back, and insides of arms, skin tingling and sensitivity, breast tenderness, pain in ovaries. Day 4: rash gone but skin sensitivity increased. Day 5-9: symptoms continued. Day 10: stomach cramping with nausea. Day 11: symptoms continued and leg cramps began. Day 13: contacted doctor after pause was noted on J&J vaccine. Dr. DX'd inflammatory response to J&J vaccine and ordered bloodwork. Day 15: severe itching started all over body, with increased sensitivity and tingling (prickly feeling). Day 15-23: itching, tingling, pins and needles feelings in feet and hands, joint and muscle pain continue. Day 23: saw doctor again, steroids recommended and referral to a Rheumatologist for further tests.

Follow up report to first VAERS report (1248256) - Entire (all over) breast tenderness (the nipple tenderness has been there since within a couple day after the vaccine - and that hasn't gone away). Dr said I'm having an inflammatory response to vaccine and they have referred me to a rheumatologist (gave me a referral) - joint pain and itching hasn't gone away at all. (The really bad rash on my neck, upper chest and torso and back on day three - that rash is gone but that tingling and itching of having the rash hasn't gone away.) I'm working still but I'm working from home - so that has been okay - although some days I feel worse then others. I noticed yesterday that my breasts were swollen/lumpiness. Was born with fiber cystic breasts - since menopause that has gotten better but now this feels like it did back then - feels like it did when I was going to start my period. I haven't had a period since five years ago. Eye sensitivity: Normally have dry eyes but it's worsened. I have to put drops in multiple times of day. I literally wake up in the middle of the night with almost a sandpaper feeling in my eyes and have to put drops on them. I have been doing acupuncture - it will be my third time today - it helps with stress and the anxiety from these symptoms. They wanted me to take steroids - I'm trying not to do something like this because I am so sensitive to these types of things.

Few days before April 8 there was a nervous breakdown trying to find my phone to leave on time to work. I knocked over shelves and smashed the printer. Then I noticed that I started my period cycle Thursday morning. I have not had my cycle in over four years. It only lasted a few days and was very thin and watery.

Pain in both pelvic limbs, left predominance, admitted to hospital for observation, admission April 23, discharged April 25, next appointment to angiologist May 3

I have been in menopause for 7 years, taking Estradiol-Norethindrone.5-.1 mg daily for the last 16 months. I have not had a menstrual cycle for more than 7 years. I began menstrual bleeding around 36 hours after receiving Jansen COVID 19 vaccine. Experienced continuous daily bleeding for 6 days. Did not experience ant other symptoms.

RHEUMATOID ARTHRITIS; NIPPLE RIGIDITY/HARD; TENDER NIPPLES; BREASTS SWELLING; BREASTS TENDERNESS; LEFT ARM TENDERNESS (INJECTION SITE PAIN); This spontaneous report received from a patient concerned a 57 year old White and not Hispanic or Latino female. The patient's height, and weight were not reported. The patient's past medical history included pulmonary embolism (left side of the lung), and concurrent conditions included lyme disease, alcoholic, non-smoker, and menopause, and other pre-existing medical conditions included the patient had no drug abuse nor illicit drug usage. The patient was previously treated with enoxaparin for pulmonary embolism (left side of the lung- difficulty/trouble in breathing, chest pain and stroke-like symptoms), and Pradaxa (dabigatran etexilate mesilate) for pulmonary embolism. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, and expiry: Unknown) dose was not reported, 1 total administered on 09-APR-2021 on left arm for prophylactic vaccination. Concomitant medications included natural hormones for menopause (antiaging to keep menstrual period as long as possible). The patient felt left arm tenderness (injection site pain) not immediately but 1 day after the patient took vaccine, on 10-APR-2021. The patient had soreness of the arm and the pain was tolerable. Patient stated that on 25-APR-2021, nipple was hard as rock, mostly left nipple (nipple rigidity/hard and tender nipples). Patient called doctor and was prescribed Primrose (Oenothera Biennis) oil pill. On the same day, patient experienced breasts swelling and tenderness, which was worse on the left breast and right breast had minimal pain. Patient stated that wearing bra and T-shirt was painful. The doctor had prescribed anti-depressant to the patient, but patient had refused to take it, not unless needed. On 05-MAY-2021, the patient was diagnosed with rheumatoid arthritis. Patient felt inflammation and pain mostly in the hand. Patient was prescribed meloxicam for rheumatoid arthritis. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from left arm tenderness (injection site pain) on 23-APR-2021, had not recovered from nipple rigidity/hard, and tender nipples, and the outcome of breasts swelling, rheumatoid arthritis and breasts tenderness was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210421576.; Sender's Comments: V0:20210509036- covid-19 vaccine ad26.cov2.s-Rheumatoid arthritis. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).

Very heavy menstrual bleeding. Bled through clothing and bedding. Lasted 2x as long as all previous months. Similar but not as heavy, occurred in May 2021 (second menses cycle since receiving vaccine).

Noted increasing breast tenderness , first on left side and then on both sides, mostly on the lower half of my breasts. May be totally normal. May be totally unrelated to the vaccination. Just wasn't sure, so that is why I reported it. Maybe started about 1-2 weeks after vaccination. Tenderness still remains at this time - not any worse than it was a week ago. Mostly tender to touch. They do not hurt otherwise. My doctor stated she did not want me to get a mammogram until after seeing me first. No redness/swelling noted. No fever.

I am 4 years menopausal. After a week and a half my nipples became sore and I had pain in lower pelvic area.

A LUMP UNSPECIFIED IN THE AUXILIARY TAIL OF THE RIGHT BREAST (DISAPPEARED AROUND 2 WEEKS AND REAPPEARED ON 02-JUN-2021 WITH CHANGE IN THE SIZE); TIRED; This spontaneous report received from a patient concerned a 57 year old female. The patient's height, and weight were not reported. The patient's past medical history included pneumonia, and concurrent conditions included environmental allergies, asthma, and smoker. The patient experienced anaphylactic reaction (not confirmed) when treated with levofloxacin, and drug allergy ( dropped her blood pressure very low) when treated with morphine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and batch number: 042A21A expiry: 21-JUN-2021) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. Concomitant medications included epinephrine for asthma, omeprazole, and vitamin d. On 06-APR-2021, the subject experienced tired. On 20-APR-2021, the subject experienced a lump unspecified in the auxiliary tail of the right breast (disappeared around 2 weeks and reappeared on 02-jun-2021 with change in the size). Laboratory data (dates unspecified) included: Mammogram (NR: not provided) lump in right breast, and Ultrasound breast (NR: not provided) Lump in right breast. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tired, and had not recovered from a lump unspecified in the auxiliary tail of the right breast (disappeared around 2 weeks and reappeared on 02-jun-2021 with change in the size). This report was non-serious.

About 2 months after shot experienced swollen painful lymph nodes in breast, arm pits, rib cage and throat. Symptoms persistent and now have large, painful lump in breast that was not there before injection. Also hives on upper body that come and go. Also extremely high CBC.

I now have a mass on my left breast that seems to have ?grown? very quickly. I will be scheduled for a biopsy soon.

Patient reported getting her menstrual cycle the morning after receiving the vaccine. She reported she has not menstruated since February of 2020.

A morning after vaccine, back pain from center of back , down pelvic area and leg on left side. This is day 2 and not getting better. Sharp needle like pain going down left back and legs. I've been taking meds that I had from a shoulder surgery. Not wanting to go to Dr right now. Previously had Covid in August 2020

I am 8 years through menopause and I am now having monthly bleeding (period) May was just 2 days of very very lite spotting, June was 3 days of lite spotting, July 4 days of lite bleeding. Read that it could last several months and go away again.

Experienced an unusual headache on about April 8th. It felt like it was behind my left eye, and in front of my left ear. Pain subsided in about an hour after resting. On April 28th, I experienced vaginal bleeding. I awoke to a dry cough and felt the leakage. The blood was bright red and I'd estimate 4-6 Tablespoons. I feel light-headed, concerned, but otherwise fine.

I have already reported that I am experiencing menstrual bleeding at age 60. In addition to that, on April 29, I experienced dizziness, fever, chills, lower back pain and joint pain. The symptoms dissipated the following day. I am still experiencing menstrual bleeding.