Age: 51.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Swelling, Urticaria
Clinical narrative: 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.