Sex: U
Vaccine: COVID19, COVID19
Symptoms: Feeling abnormal, Heart rate, Heart rate increased, Lip swelling, Oxygen saturation
Clinical narrative: DIARRHEA; VOMITING; DEHYDRATED; FASTER HEART RATE; LIP SWELLING; TONGUE SWELLING; FEELINGS AROUND MOUTH; CHILLS; TIRED; OXYGEN LEVELS DROPPED DOWN; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose was not reported, administered on 06-APR-2021 09:10 am for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 06-APR-2021, shortly after about 5-10 minutes of vaccination, the patient started experiencing feelings around mouth and lips and tongue got swollen. The Paramedic on site gave 2, 25mg of Benadryl and monitored the patient for 45 minutes and things settled. The patient was released to come home where, the patient began experiencing chills that lasted for about 2 hrs. The patient was tired which was normal but oxygen level dropped to 90 so, the patient had oxygen in house for a breathing situation; then the patient was okay about 3 hours later. On 07-APR-2021, approximately about 4:00 am, the patient had severe vomiting and diarrhea. Vomiting and diarrhea lasted for about 5 hrs. The patient was dehydrated and went to the emergency room (ER) where an electrocardiogram (EKG) was done as the patient had a fast heart rate. The patient was administered IV fluids and monitored for about 3 hrs. Chills returned but the patient came home at about 1:00 pm. The patient stated that the reaction showed that immune system of the patient kicked in. The patient was slowly advancing the diet and was doing better at the time of this report.  Laboratory data included: OXYGEN LEVEL (NR: not provided) on 06-Apr-2021 was 90, ECG (NR: not provided) on 07-Apr-2021 was UNKNOWN, and Heart rate (NR: not provided) on 07-Apr-2021 was FASTER. Treatment medications (dates unspecified) included: 2 doses of diphenhydramine hydrochloride of 25 mg for lips swelling & tongue swelling and feelings around mouth and oxygen for oxygen level dropped and IV fluids for diarrhea, vomiting, dehydrated. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from oxygen levels dropped down, and lips swelling and tongue swelling, on an unspecified date and from diarrhea, and vomiting on 07-APR-2021, and was recovering from chills, tired, faster heart rate, dehydrated, lips swelling and tongue swelling, and feelings abnormal. This report was serious (Other Medically Important Condition).; Sender's Comments: V0;20210421308-covid-19 vaccine ad26.cov2. s- oxygen levels dropped down, Severe diarrhea, vomiting, dehydration ,lips swelling and tongue swelling, faster heart rate. This events are considered unassessable. The events have a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the events.