Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anxiety, Fungal infection, Haemorrhoids thrombosed, Headache, Therapy non-responder
Clinical narrative: CONFIRMED IMMUNOLOGICAL VACCINATION FAILURE; HEMORRHOIDS THROMBUS; YEAST INFECTION IN PRIVATE AREA; HEADACHE; WORRIED; This spontaneous report received from a patient concerned a 41 year old female. The patient's height, and weight were not reported. The patient's past medical history included: thalassemia, and hemorrhoid, and concurrent conditions included: high blood pressure, hypothyroidism, and chronic migraine, and other pre-existing medical conditions included: Patient did not have any allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total, administered on 06-MAY-2021 to right arm for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported.  On 06-MAY-2021, one hour after vaccination the patient experienced headache. Patient was able to move around, pain scale of headache was 5 on a scale of 1 to 10 with 10 being highest, and patient stated that she was working that day. On 08-MAY-2021, yeast infection developed in her private area. Patient stated that she had no sex one week before or after and she believed that infection was not caused by it and she felt odd about it, yeast infection healed after 3 days. On 09-MAY-2021, the patient experienced hemorrhoid thrombus that externally developed after 3 to 4 days of receiving vaccine and doctor had to cut the hemorrhoid, patient was worried about it, patient stated that she has had hemorrhoid before but never had a doctor to lacerate the thrombus. On 06-OCT-2021, severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) antibody test was negative with no biotin interference, 1200mcg/ml, she stated that some studies have shown it could reach up to 355, she stated that before receiving Janssen vaccine pin prick test was negative. Patient had been tested negative multiple times for covid but was wondering why her antibody test was negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from hemorrhoids thrombus on 10-MAY-2021, yeast infection in private area on 11-MAY-2021, and headache on 06-MAY-2021, and the outcome of confirmed immunological vaccination failure, and worried was not reported.  This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000196797.; Sender's Comments: V0- 20211017191-covid-19 vaccine ad26.cov2.s-confirmed immunological vaccination failure. 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: SPECIAL SITUATIONS 20211017191-covid-19 vaccine ad26.cov2.s-hemorrhoids thrombus. 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: MEDICAL HISTORY, UNDERLYING DISEASE