Moderna

Vaginal bleeding that started 1 day after receiving first dose; ultimately diagnosed with endometrial/uterine cancer

Very heavy postmenopausal bleeding including large clots began evening of 3/12/21; ended 3/22/21. Bleeding occasionally heavy for entire time. No other symptoms.

Patient stated 2 weeks after receiving the 2nd dose, left breast was tender (tissue-pressure). Arm soreness and breast tenderness still continuing. Primary recommended mammogram and lymphoid exam.

2 days after vaccination: Muscle pain in both thighs - difficult to sit, squat, get out of a chair, difficulty climbing stairs Hip, pelvis, and butt pain in the muscles, hip bones as well Right arm, shoulder, back, neck pain Swollen joints in hands, stiffness especially in the morning Prescribed Prednisone for pain, 30 MG gradually weaned over 5 months. Still extreme pain and difficulty performing daily tasks - weaned due to it being only a short term solution. Overall arthritis-like symptoms in joints that never experienced arthritis before, either from age or injury.

#1 Moderna 1/24/2021 1500 #2 Moderna 2/21/2021 1500 #1Moderna lot 029L208 #2Moderna lot 039K208 Side effects started that day after, that include pain to abdomen, chest, pelvic area and chills, felt feverish did not check temp, headache, injection site pain. Did the adverse event start after the first or second vaccination? Side effects started after each vaccines the following day, she just now realized this today. Symptoms severity about the same compared to 1st shot. Symptoms started resolving after a week or so.

4/29/21: HAD BLURRED VISION (ALL DAY UNTIL MORNING OF NEXT DAY) + PRESSURE IN HEAD (ALL DAY INTO EVENING OF NEXT DAY) ABOUT 40 MINUTES AFTER RECEIVING VACCINE. 4/29/21: EVER SINCE VACCINATION, EXPERIENCING EXCESSIVE THIRST. ONGOING 5/1/21: PATIENT DESCRIBED SYMPTOM AS SKULL BONE PAIN (TENDER SCALP WHEN TOUCHED) UNTIL 5/5/21 5/3/21: ONGLING BLADDER IRRITATION. NO BLOOD IN URINE, BUT SOME SPOTTING (~2TSP) ON PADDING 5/17/21 . NO BLOOD PRESENT SINCE 5/4/21 MORNING: LYMPH NODE SWOLLEN UNDER THE LEFT ARM (INJECTION WAS IN RIGHT ARM). SIZE OF A TENNIS BALL, VERY PAINFUL, AND PAIN RADIATED TO AROUND THE LEFT BREAST AREA. PAIN LASTED UNTIL THE AFTERNOON OF 5/6/21. 5/9/21: BLOOD CLOT IN LEFT LEG REACTIVATED IN THE MORNING, ACCOMPANIED BY EXTREME PAIN, SWELLING, WARM TO THE TOUCH. PAIN AND SWELLING HAS BEEN MINIMAL BEGINNING 5/24/21, AND HAS NOT BEEN AS WARM TO THE TOUCH AS IT HAS BEEN. TREATMENTS: TOOK IBUPROFEN AND TYLENOL AS NEEDED FOR PAIN. USED ARNICA GEL ON THE ARM AT THE INJECTION SITE + MASSAGE+ CONSTANT MOVEMENT FOR PAIN/STIFFNESS. USED ARNICA GEL ALSO ON LYMPH NODE UNDER LEFT ARM ELEVATED CLOTTED LEG AND STAYED ACTIVE TO OPTIMIZE BLOOD FLOW, USED LIGHTLY HEATED PAD TO EASE THE LEG PAIN

Bleeding from private area, went to walk-in clinic vitals were bad. Sent to Hospital, was kept for 7 hours. Was prescribed antibiotics. Vomiting, nauseous.

Broken of the right eye vein that led to bleeding; excruciating pain (like a labor pain; Diarrhea; vaginal bleeding; Dizziness; Stomach Cramping; A spontaneous report was received from a consumer who was also a 82-years-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and who experienced: excruciating pain - like a labor pain (pain), stomach cramping (abdominal pain upper), diarrhea, vaginal bleeding (vaginal haemorrhage), dizziness and broken of the right eye vein that led to bleeding (eye haemorrhage). The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included: methotrexate. On 22Jan2021, the patient received their first of two planned doses of Moderna's COVD-19 Vaccine (mRNA-1273, lot number: not provided) intramuscularly for prophylaxis of COVID-19 infection. Later on 22Jan2021, the patient began to develop: excruciating pain - like a labor pain (pain), diarrhea, vaginal bleeding (vaginal haemorrhage), dizziness and broken of the right eye vein that led to bleeding (eye haemorrhage). She reports these events lasted for 1 day and then stopped. The patient states she still experiences stomach cramping (abdominal pain upper), The patient confirmed she consulted with her physician and blood work was done. The results of the blood work were not provided. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. Patient is wondering if these events are normal and if she should receive her second dose. The outcome of the events: excruciating pain - like a labor pain (pain), diarrhea, vaginal bleeding (vaginal haemorthage), dizziness and broken of the right eye vein that led to bleeding (eye haemorrhage) is considered to be resolved based on patient reported duration of 1 day. The outcome of event: stomaching cramping (abdominal pain upper) is considered not recovered/not resolved per patient report.; Reporter's Comments: This case concerns a 82-years-old, female patient who experienced: excruciating pain- like a labor pain, abdominal pain upper, diarrhea, vaginal bleeding, dizziness and eye haemorrhage. Very limited information regarding this events has been provided at this time. Further information has been requested.

3/25/2021 was at store when she felt weak, dizzy and nauseated. She had severe left lower pelvic pain above her left hip. Heart rate was 40 and blood pressure was very low. Was taken to local ER. CT of chest revealed pulmonary embolism in the right lower lobe, left retro-peritoneal hemorrhage and large intramural thrombus in the inferior aspect of the IVC extending into the left common femoral vein and superficial femoral vein. Platelet count 147. After initial treatment in ER, she was transferred to another Hospital for hemorrhage and large thrombus. She was eventually released to rehab.

A lump has formed under her right arm and breast. Her physician has scheduled her for a scan and says the lump needs to be removed.

SEVERE PAIN IN PELVIC JOINTS, UNABLE TO GET OUT OF BED. SEVERE PAIN ENTIRE LEFT ARM FROM NECK TO FINGERS, UNUSUALLY SEVERE CHILLS, LIGHTHEADEDNESS/DIZZINESS.

pt is here to receive 2nd dose of Moderna vacc. & she stated 1st dose caused some soreness to the arm & slight fatigue but she noticed blood upon urination after 1st dose on that afternoon. It was not bright red blood but was dark/brick red color like menstrual break through bleeding she did not notice pain associated with it . She did not notice any more vaginal bleeding after the incident. She reported to her PMI, & PMP OK'ed for her to get 2nd dose but to call him if the same urination occurs @ 2nd dose pt abn on Estradiol(HRT)

Sore and swollen left breast two days after first shot. Two months later still swollen and sore. Repeat mammogram and ultrasound were normal. Now applying warm moist compresses twice a day.