Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Gastroenteritis viral, Heart rate, Hypersomnia, Hypertension, Injection site erythema
Clinical narrative: STOMACH FLU; CHEST PAIN UNSPECIFIED; SHORTNESS OF BREATH; EKG SINUS TACHYCARDIA, LOW VOLTAGE PERIODICAL, UNCONFIRMED DIAGNOSIS; DIZZINESS; SLEEPING 14 HOURS; LARGE NODULE AT INJECTION SITE; SWELLING AT INJECTION SITE; REDNESS AT INJECTION SITE; SORENESS/PAIN AT INJECTION SITE; HIGH BLOOD PRESSURE; This spontaneous report received from a patient concerned a 40 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known allergies. The patient was not pregnant at the time of report. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, expiry: 23-JUN-2021) dose was not reported, administered on 09-APR-2021 in left arm for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021 (following vaccination), the patient's area around the injection site was swollen, a large nodule formed, it was red, sore and painful. These local symptoms lasted for a week then disappeared. The patient felt very fatigued, and reports sleeping 14 hours that night. On 10-APR-2021 the patient experienced headache and felt like his head was in a vise around each cheekbone. The fatigue and headache was gone on 11-APR-2021. On 19-APR-2021 the patient had vomiting and diarrhea for about 16 hours. The local symptoms swelling, redness, pain at injection site reappeared. On 19-APR-2021 the patient was very fatigued and took Pedialyte (calcium chloride/glucose/magnesium chloride/potassium chloride/sodium chloride/sodium lactate) to get rehydrated. On 21-APR-2021, the patient visited the emergency room as new symptoms appeared stomach pain, chest pain, shortness of breath and dizziness and her blood work and electrocardiogram(EKG) was done. The health care professional(HCPs) ruled out heart attack and told patient nothing in the symptoms or blood work warranted a scan for blood clots. The patient received anti-nausea intravenous (IV) medication, diagnosis of stomach flu and was sent home. The patient reports that her blood pressure readings were 144/104 and a pulse was 119. The emergency room health care professional instructed the patient to follow up with doctor and discharge diagnosis was made as chest pain unspecified. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from swelling at injection site, redness at injection site, soreness/pain at injection site, and large nodule at injection site, had not recovered from chest pain unspecified, shortness of breath, dizziness, and EKG sinus tachycardia, low voltage periodical, unconfirmed diagnosis, and the outcome of stomach flu, high blood pressure and sleeping 14 hours was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210443030-covid-19 vaccine ad26.cov2.s-Stomach flu. This event(s) is considered unassessable. 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).