Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Electrocardiogram, Electromyogram, Exercise tolerance decreased, Gastrointestinal disorder, Impaired work ability
Clinical narrative: BASICALLY DISABLED; SHORTNESS OF BREATH; WEIGHT LOSS; CHEST PAIN; DIGESTIVE ISSUES; HEART BEATING FAST; GASTRITIS; RECTAL BLEEDING; CHANGES IN PERIOD NOW EVERY 3 WEEKS (PERIOD SHORTER CYCLE); BLEEDING LASTS 6-7 DAYS (LONGER BLEEDING); INSOMNIA; This spontaneous report received from a patient concerned a 40 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was previously received Pfizer Biontech Covid-19 Vaccine (tozinameran) (dose Number in Series 1) (form and route of admin not reported, batch number: unknown expiry: unknown) dose was not reported, administered on an unspecified date in 2021 (one year ago) for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with first dose of Pfizer Biontech Covid-19 Vaccine (tozinameran) (dose number in series 1). The patient additionally received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, batch number: 1855835 expiry: unknown) dose was not reported, 1 total, vaccinated on right arm, administered on 26-FEB-2022 for prophylactic vaccination. Age at time of vaccination 40 years old. No concomitant medications were reported.  On 27-FEB-2022 (the day after the vaccination), the patient experienced heart beating fast and chest pain. She described a pinching pain on the left, travelling to her chest and pain in the middle of her breast bone in the middle of her chest and more to the left even though she was vaccinated in the right arm(dose number in series 2). On the same day, the patient experienced digestive issues and stated that she started going to the bathroom more and food was coming out of her very fast. She was initially trying to eat more, but she can't do that anymore. she also experienced weight loss about 15 lbs (dose number in series 2). She was basically disabled and stated that she can't drive or go for shopping and quit her job (dose number in series 2). She also had horrible shortness of breath (dose number in series 2). She has been to ER (emergency room) 10 times and was twice hospitalized (dates unspecified). On an unspecified date, the patient experienced rectal bleeding (dose number in series 2). On an unspecified date, patient had CT scan of lungs and no blood clots. On an unspecified date, she experienced changes in her period which was every 3 weeks (used to be every 28 days) and bleeding lasts for 6-7 days (longer bleeding) her first cycle after vaccination and 5 days the 2nd cycle (instead of 3-4 days like it used to be). On APR-2022 (since mid-April), She had insomnia and she hasn't slept in the last 3 weeks. She stated that it was now little better as she was taking melatonin. On an unspecified date, she had gastritis (dose number in series 2). On an unspecified date, she underwent autoimmune tests and endoscopy the results were waiting (not reported). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from insomnia, had not recovered from heart beating fast, chest pain, changes in period now every 3 weeks (period shorter cycle), weight loss, and bleeding lasts 6-7 days (longer bleeding), and the outcome of digestive issues, rectal bleeding, gastritis, shortness of breath and basically disabled was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0:20220610772-Covid-19 vaccine ad26.cov2.s- Basically Disabled, Rectal Bleeding, Heart Beating Fast, Shortness Of Breath, Chest Pain, Digestive Issues, Weight Loss. The event(s) 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(s). Therefore, this event(s) is considered unassessable.