Johnson & Johnson

The patient received Janssen COVID vaccine on 3/6 to RIGHT deltoid. She has a past medical history significant for LEFT sided breast cancer, treated with lumpectomy and radiation ~5 yrs prior. Remains on Letrozole. 1 day post-vaccine, she developed fevers (tmax 104), chills, malaise. 2 days post-vaccine, the fevers, chills, malaise dissipated but she developed a "rash" to her LEFT breast (same site as prior malignancy). This rash became a widespread erythematous area encompassing her entire breast. Axilla excluded. No palpable lymphadenopathy. She reports area to be tender and itching. Rash is blanchable. It is somewhat response to OTC antihistamines (Claritin/Benadryl) and OTC hydrocortisone. She has no respiratory distress, lingering fever, or other allergic reactions. She was given a prescription topical steroid (triamcinolone) and will follow up with her in a few days, if she remains stable. If not back to baseline within the week, will obtain breast MRI for further evaluation.

On the evening of 04/11/21 patient states she began to have some vaginal blood spotting, on Monday 04/12/21 patient reported vaginal blood flow. Patient reports she is post menopausal and has not had a period, spotting, or blood flow in years.

6 days after vaccination I noticed tenderness in lymph nodes in both breasts and down sides of under arms.

I am a postmenopausal woman (10 years) but in the evening after I received my Covid shot that morning I experienced vaginal bleeding. Not a lot, just several drops, but I have had no vaginal bleeding for many years and it was very unusual. It didn?t persist. I just had it enough to observe and didn?t see it again after changing undergarments.

Pt had postmenopausal bleeding starting on 3/30-4/3. Workup with u/s was negative. Pt had burning with bowel movement on 3/29, felt like a "habenero pepper." Also had itching and rash of chest wall, right breast, back. Received her shot in the left arm.

Onset next day Chills. Fever, body aches, joint pain, abdominal pain, left breast swelled to double the size

Whether the adverse events were caused by the vaccine is to be determined. We are available to discuss more details if this information can be used to help others from experiencing these reactions. The morning after getting the vaccine, patient discovered that she could not swallow. As her condition worsened, she was taken to the emergency room. Over the past month, patient went to the emergency room 4 times. The last time resulted in extended hospitalization that continues to this day. In addition to the swallowing problem, two other major adverse events need to highlighted. First, on 27 March, while in the hospital, vaginal bleeding started. On 29 March, her doctor, performed a hysteriscopy/DNC finding " "an unexplained blood clot (hematoma)." The second major event was when patient demonstrated significant confusion and lack of memory. On 7 April, she was diagnosed with Metabolic Encephalopathy. Neurologists at the hospital suspected that her MS was reacting to her UTI and once the infection is eliminated her memory should come back. But as of 10 April, she was still having issues including hallucinations. Although she is eating some as of 13 April, she is still very weak and will likely by moved from the Hospital to a rehab facility. She still does not remember much of the last 37 days.

2 Straight Days Headaches 7/20/21-7/21/21 I Don?t Get Headaches 7/22/21 cramps in stomach light blood through 7/23/21 heavy dark blood with light clotting. 7/25/21-7/26/21 large blood clots until 7/28/21. 0n 7/28/21 called Primary Physician for a Consultation it?s scheduled for Friday. I have enormous swelling in my Right leg in rear upper thigh. I have decided to go to Emergency Room. I have a slight headache and after Blood completely stop I am now seeing very light blood. I?m 61 I had stop having periods at 58!started back when I first took John & Johnson shot. I reported here before.

I am 7 years post-menopausal, and 6 weeks after the vaccine I had a week-long, full-fledged menstrual period. Then for the next five or six weeks, I had 4 or 5 hot flashes every day (I never had any in my 7 years of being post-menopausal). I also had a migraine mid morning every day after the menstrual period. They have lessened now (tapered and mostly stopped by end of June 2021). I also have slight balance problems now, that are still ongoing.

got it April 10th First day fine, second-day urine dark, third-day fog and disoriented sensation in my head and double vision, and periods of weakness in hands (now coming and going), lack of appetite, extreme thirst, no fever, no vomiting, pains in my thighs and stomach, middle back pain, Hips, pelvis, 9th day: calves so painful and tight I could not get out of bed, figures swelled up to the point that I could not put on my finds, 10th day my calves are very painful (like the soreness that is felt after someone punches you) Especially right calf. The batch number is 206a21a if I can read it from my card.

Began my yearly physical two days after the vaccine, as did my husband. Both of our urine tests showed blood in our urine. Had a second urine test a month later. Still had blood in urine. Also had 3 weeks of diarrhea. That was followed by a vaginal yeast infection. Given a prescription to clear that up. Then my breasts became swollen and painful. It has been ten weeks since the vaccination. Saw a urologist this week there is still blood in my urine. The amount of blood has decreased, but still showing up.

I have not had a menstrual cycle for 10 years, no spotting or anything. The day after getting vaccine I had slight bit of blood discharge. After the slight discharge it stopped and I feel good.

HAD PERIOD AGAIN; FLU-LIKE SYMPTOMS; This spontaneous report received from a patient concerned a 64 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included hormone replacement therapy, menopause, no alcohol use, and non-smoker, and other pre-existing medical conditions included the patient had no known drug allergies and no history of drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, expiry: 13-JUN-2021) dose was not reported, 1 total administered on 30-MAR-2021 to left arm for prophylactic vaccination. Concomitant medications included estradiol, progesterone, and testosterone. On 30-MAR-2021, the subject experienced flu-like symptoms. On 30-MAR-2021, on the same day of vaccination the patient experienced symptoms such as flu-like symptoms, headache, extreme fatigue and runny nose that had lasted for 2 days. On 11-APR-2021, the patient started having period again. The last time she had period was 20 years ago. She was on natural hormone replacement therapy, a mixture of estrogen, progesterone and testosterone for the last six months from the time of this report and the patient was not sure if the period was side effect from the vaccination or from her hormone replacement therapy. The patient had notified her hormone replacement therapy physician and would be going for an ultrasound scan the day after this report. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu-like symptoms on 01-APR-2021, and had not recovered from menstruation. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 -Covid-19 vaccine ad26.cov2.s -Post menopausal bleeding. This event is considered not related. The event 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 than the drug. Specifically: CONMEDS-OTHER SUSPECT DRUGS

Very Large (size of an egg swollen lymph node) came on suddenly 2 1/2 weeks after receiving the vaccine in the same arm. It was located 16 cm from the nipple. Took 10 day antibiotic - relieved the throbbing and decreased somewhat in size but still there. After initial ultrasound a biopsy was insisted upon by all Dr.'s involved. They were very concerned by the looks of the ultra sound images. I insisted on waiting 2 additional weeks. On 4-27 returned for a mammogram and follow up ultra sound. Mammogram was normal and lymph node had decrease 1/2 in size making the Dr.'s agree a biopsy was not needed and most likely the result of the J & J vaccine.

Four days after receiving her Covid vaccination patient started bleeding vaginally. Had blood clots and large amount of blood and it lasted 2 weeks. Patient has been post-menopausal for 10+ years.

CHILLS; BLOATING; ITCHING TO LEFT LOWER ARM/LEFT UPPER; SWOLLEN AND TENDERNESS TO LEFT AXILLA TOWARDS BREAST; ACHING IN NECK; NECK SWELLING; MASSIVE HEART ACHE; NAUSEA; FEVER 100.6 F; MASSIVE HEADACHE TO FRONTAL AND TEMPORAL LOBES; RINGING TO LEFT EAR/RIGHT EAR; This spontaneous report received from a patient concerned a 66 year old female. The patient's weight was 117 pounds, and height was 61 inches. The patient's past medical history included pain to arm, inflammation, swollen neck, and fever 102 f, and concurrent conditions included non-smoker, and non-alcohol user, and other pre-existing medical conditions included the patient has no history of drug abuse or drug illicit use. She had a history of severe immune reaction to the Pneumovax (pneumococcal vaccine polysacch 23V) in 2019 which caused excruciating pain to arm and inflammation with swollen neck with 102 F and had to call 911. Paramedics stated stable and not taken to the hospital. The patient also experienced drug allergy when ibuprofen, neomycin, and magnesium sulfate/potassium sulfate/sodium sulfate. 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 to the left arm, on 31-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 31-MAR-2021, the patient experienced ringing to left ear and right ear. On 01-APR-2021, the patient experienced massive heart ache, massive headache to frontal and temporal lobes, rapid heart rate, pain near sternum that radiated downward, sensation of pressure at breast level, neck swelling, aching in neck, gastrointestinal upset, solar plexus, nausea and fever 100.6 F. On the same day, the patient went to urgent care and was given Zofran 4 mg sublingual. They took the lab at the urgent care. On 01-APR-2021, the patient's laboratory data included: Absolute lymphocyte count (NR: not provided) 0.7 (units not provided), Blood glucose (NR: not provided) 106 mg/dL, Body temperature (NR: not provided) 100.6 F, Chest X-ray (NR: not provided) normal, Complete blood count (NR: not provided) normal, Electrocardiogram (NR: not provided) normal, Heart rate (NR: not provided) Rapid, Lymphocyte count (NR: not provided) 11 % (low), Neutrophils (NR: not provided) 81 % (high), and Troponin I (NR: not provided) normal. On 02-APR-2021, the patient experienced swollen and tenderness to left axilla towards breast. On 05-APR-2021, the patient experienced itching to left lower and upper arm. On 08-APR-2021, the patient experienced bloating, pain from gas and increased changing of bowel habits. On 18-APR-2021, the patient's headache reappeared. On 19-APR-2021, the patient experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from ringing to left ear/right ear on 06-APR-2021, aching in neck, neck swelling, and nausea on 01-APR-2021, swollen and tenderness to left axilla towards breast, and itching to left lower arm/left upper on 05-APR-2021, chills on 20-APR-2021, and fever 100.6 f on 02-APR-2021, was recovering from massive headache to frontal and temporal lobes, had not recovered from bloating, and the outcome of massive heart ache was not reported. This report was serious (Other Medically Important Condition). Initial information was received on 20-APR-2021, with additional information obtained via telephone follow up from a patient on 21-APR-2021, the following information was updated and incorporated into the case: events added (Ringing to left ear and right ear).; Sender's Comments: V0 : -covid-19 vaccine ad26.cov2.s -Massive heart ache. This event is considered unassessable. The event 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.

4 days after the vaccine I started my period. light spotting and cramps 6 weeks after the vaccine I woke up with a typical burst blood vessel in my right eye. I realized my actual eye color changed from hazel to blue. As silly as this sounds the color change is not the typical "I was wearing blue, so my eyes looked blue" It changed from hazel to blue overnight. The blood vessel healed, the eye color change has remained. Its pretty but a little strange. It is over 3 weeks.

Extreme Swollen lymph nodes under both armpits; today, I still have swollen lymph nodes and very sensitive breasts/nipples. I just went to my OBGYN yesterday, and there are no lumps, but she confirmed swollen lymph nodes after 2 months. I will be getting a bi-lateral ultrasound on Friday.

Patient with questions /concerns-said she had to get vaccine because of recent dx/tx for breast cancer. She said received vaccine on 3/13- then on 3/16 she was seen for one of her breast cancer therapy sessions- they have been treating her for lymphedema - she said she has been going for breast cancer in July- no chemo just radiation- surgery of breast with removal of seven surrounding lymph nodes. She was advised to wear a compression bra- on 3/16 and ever since then her left side of neck has been sore- thought it was likely related to compression bra not fitting correctly b/c too tight & was professionally fitted on her- the straps seem very tight over the collar bone area that was damaged/irritated by the radiation she received on that side up through Oct 2020 for cancer. Now when she saw story today in news she got concerned could the neck soreness really be from a blood clot? She as been going the week for tightness in neck to physical therapy which started yesterday for lymphedema. Again her radiation ended Oct 2020 but she has had persistent swelling in breast & fluid in lymph nodes on the left side. She still has pain in on collar bone- on same side of radiation- blisters, sore, red. As well as this new compression bra having two tight straps on each side. Her COVID vaccine shot in right arm but left side where breast surgery was She went on 3/16 for consultation on breast lymphadema - that was when told her to wear tighter bra for compression on 3/16. She is going today to be fitted for new one that is not so tight. She is approx. 4 weeks post vaccination & post when started wearing that tighter bone- maybe three inches from where had radiation injury is located.

~36 hours after vaccine had expected reaction (site reaction, pain, fatigue, fever). One week later experienced repeated site inflammation and pain; new muscle pain across back, and sore, tender to the touch skin around breast and up to collar bone, body aches and fatigue. Resolved and arm pain restarted again 1 week later(4/22/21) (took 2000 mg of Tylenol without effect). when speaking with patient on 4/23/21 arm pain currently the only symptom.