Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Paraesthesia oral, SARS-CoV-2 test, Sinusitis, Ultrasound Doppler
Clinical narrative: MENSTRUAL BLEEDING; CYSTS APPEAR IN THE BREASTS; CYSTS APPEAR IN THE OVARIES; ELEVATION IN ESTRADIOL; FELT NUMBNESS IN CALVES; CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; LACK OF ENERGY; PAIN IN BACK; PAIN IN THE BACK OF THE NECK ON THE RIGHT SIDE; TINGLING IN THE CALVES; TINGLING IN THE MOUTH; THROBBING PAIN IN THE RIGHT NAPE OF THE NECK; SINUSITIS; This spontaneous report received from a patient concerned a 42 years old female of unspecified race and ethnicity. The patient's weight was 69 kilograms, and height was 175 centimeters. The patient's pre-existing medical conditions included the patient had not taken any other dose of vaccine for Covid-19, the patient had no illness at time of vaccination. The Patient had no past history of similar event. The Patient never had altered health exams, but had post-vaccination. The Patient undergoes regular exams, including thrombolism exams and never had any changes. The patient had no adverse event after any previous vaccinations and no history of allergy to vaccine, drug or food. The patient had no pre-existing acute illness 30 days prior to vaccination and no history of hospitalization in last 30 days. The patient had no family history of any disease or allergy (relevant to vaccination). The Patient was not pregnant at the time of vaccination and was not Breastfeeding. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: Unknown) dose was not reported, 1 total, administered on 27-Apr-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included intrauterine contraceptive device for more than three years for drug used for unknown indication.  On the day of Vaccination, the pharmacist instructed her to take 500 ml of water and as she was afraid, she ingested 3 liters of water and went for the vaccination. On 27-Apr-2021, minutes after receiving the vaccine, she began to feel tingling in her mouth and calves. The tingling in her calves stopped but she still feels numbness in the region. On the same day of the vaccine, she developed severe headaches that concentrated from the middle of her forehead to the middle of her head, and then developed pain that throbbed in the right nape of the neck. The patient still feels pain in the back of her neck, the pain that comes and goes. The patient stated that in the first 60 days after the vaccination it was more intense and then it started to be intermittent. On 28-Apr-2021, the day after the vaccination, she started to feel pain in her back (the bra strap region radiating to her neck). The patient undergoes regular exams, including thrombolism exams and stated never had any changes, but regardless of her health history, the patient's gynecologist prescribed her Aspirin 100mg/day after vaccination for unknown indication. The patient stated that when she returned to   after 10 days of vaccination, the back pain and tingling in her mouth had passed, but the headaches and tingling/numbness in her right calf continued. Upon returning the patient went for her regular check-ups to renew her license at ANAC and while performing checkups it was discovered the gynecological illness (Alteration of Estradiol (Estradiol with high rate as if patient had cancer) and cysts in the breast and ovary). The patient reported that the exams had no malignant results and the medical indication was only to follow up with routine exams and treatments were not prescribed. As the months went by the symptoms subsided and she began to feel well and fully recovered. On 03-Aug-2021, the patient again had severe headaches like the ones she had post vaccination, she was attended to in an emergency where she was tested for Covid, results were negative. The patient was not medicated on that occasion. On 06-Aug-2021, the patient started to have severe headaches again and felt it was very similar to sinusitis. The patient sought new assistance at the emergency department and the doctor on duty examined it, requested an X-ray of the sinuses and a COVID exam. The Covid test was negative, and the sinus X-ray showed little secretion, the patient had no fever, cough or runny nose. The doctor diagnosed it as sinusitis and started treatment with antibiotics (Amoxicillin + Clavulanate 875mg) for 2 days. The patient stated that when she took the 3rd dose she was unable to stand the headache. The patient contacted the doctor who took care of her husband and children when they had Covid-19 and reported the entire case. The doctor changed the antibiotic (levofloxacin 750mg, 1 for 7 days) and requested blood tests and tomography. On 08-Aug-2021, Sunday, she started to feel better, but the headache persisted. On 09-Aug-2021, Monday, she underwent RTPCR again and the result were positive for COVID-19. On the night of 09-Aug-2021, she felt the same pain in her back as she had in the post-vaccination (from the middle of her back to the top) and was a little "nasal speech", the doctor assured that her that she was probably in 4 or 5 days of virus contamination. On Tuesday of 10-Aug-2021, the Patient woke up with an unbearable headache and could not open her eyes or put her feet on the floor from headache. The tomography of the brain was Normal, but the chest tomography showed 30% compromised lung. That day the doctor prescribed other medications and the doctor stated that she was in the inflammatory phase. The doctor changed the corticoid and prescribed other medications: Hydroxychloroquine for 5 days, Ivermectin for 5 days, anticoagulant dose increased to 100mg/day, started to take 100mg/2xday, intensified Vitamin D and Zinc, (levels of Vitamin D dropped a lot after the diagnosis of COVID-19). After confirming the inflation and lung involvement and the headache did not go away, the doctor prescribed Colchicine 0.5mg (2x/day for 7 days; 1x/day for 10 days), Spironolactone 50 mg/ daily for 10 days, Cimecort spray 6/200mcg twice a day, Predsim (40 mg 3 tablets on the first day- 80mg/day for 4 days; 40mg/day for 5 days). After the end of Predsim, the patient still had pains in the body and lack of energy, the doctor prescribed Curcuma 500mg/day, Quercetin, and went back to the 100mg/day dose of preventive aspirin and the patient was taking it until the time of reporting. On 03-Sep-2021, the patient still felt little headache, pain in the back of the neck on the right side, and pain in the back (middle of the back, near the scapula on the left side). The patient plans to go to the cardiologist for routine tests. The patient also stated that she lost her sense of smell but recovered completely. Post vaccination, the patient underwent exams related to trobolism, as it is required at work (Doppler and blood tests) and the results were all within the normal.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from menstrual bleeding, cysts appear in the breasts, cysts appear in the ovaries, elevation in estradiol, and throbbing pain in the right nape of the neck, and tingling in the calves, and tingling in the mouth on 27-MAY-2021, was recovering from sinusitis, had not recovered from pain in back, felt numbness in calves, lack of energy, and pain in the back of the neck on the right side, and the outcome of confirmed clinical vaccination failure and confirmed covid-19 infection was not reported. This report was serious (Other Medically Important Condition).  This report is associated with product quality complaint.  Following receipt of additional information, it was determined that nullification was required for 20210803282. The information indicated that 20210803282 originated from  as previously reported. Therefore, this case 20210920710 was created to correct the country of primary source. All relevant information will be submitted under new case.; Sender's Comments: V0: 20210920710- covid-19 vaccine ad26.cov2.s-Confirmed clinical vaccine failure. 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: SPECIAL SITUATIONS