Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling drunk, Headache, Heavy menstrual bleeding, Hypertension, Injection site pain
Clinical narrative: HORRIBLE PAIN IN LEFT ARM AT INJECTION SITE; LOSING BALANCE; VERY HIGH BLOOD PRESSURE DUE TO PANIC ATTACKS; EARLY AND HEAVY PERIOD (ON DAY 20 OF MENSTRUAL CYCLE); EARLY PERIOD; CHEST PAIN THAT MOVED TO HER BACK; DIFFICULTY BREATHING; 2 HORRIBLE PANIC ATTACKS; DIZZINESS; FELT DRUNK; HEADACHE; SHIVERS; This spontaneous report received from a patient concerned a 47-year-old female. The patient's weight was 137 pounds, and height was 63 inches. The patient's past medical history was significant for chest pain after going on a trip. The patient's concurrent conditions included was drug allergy (Acetomycin (Penicillin) esomeprazole, oral steroids), stress, celiac disease, hormonal changes, perimenopause, nonsmoker, non-alcohol user, gluten intolerant, and exercising. Past products were benzylpenicillin, esomeprazole, and oral steroids for drug used for unknown indication. On 06-APR-2021, the patient received primary vaccination with covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of administration, batch number and expiry were not reported) dose was not reported, for prophylactic vaccination.  No adverse events were reported following administration of covid-19 vaccine ad26.cov2.s. (Dose number in series 1). On 25-OCT-2021, the patient received a booster vaccination with covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, batch/lot number: 1855194, and expiry: unknown) dose was not reported, 1 total, administered on right arm on for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date in OCT-2021, the patient experienced shivers. On 25-OCT-2021, the patient experienced dizziness (serious event) (dose number in series 2). On 25-OCT-2021, the patient experienced felt drunk, horrible pain in the left arm, headache (dose number in series 2). On 28-OCT-2021, the patient experienced chest pain that moved to her back, difficulty breathing and 2 horrible panic attacks (serious event) (dose number in series 2). On 29-OCT-2021, the patient could not go to work due to her symptoms. On 30-OCT-2021, the patient stated that she thought she was going to have a heart attack because of all the symptoms and visited urgent care. The patient stayed in urgent care for 3-4 hours. The following diagnostic and laboratory tests were performed while at the urgent care: test for blood clot was inconclusive, chest x-ray, electrocardiogram (EKG) every hour, and a bag of saline solution due to losing balance. A computerized tomography (CAT) scan was also performed to rule out pulmonary embolism. The result of all tests were reported by the patient to have come back as normal. At an unspecified time the patient was rushed to the Emergency Room (ER). On 31-OCT-2021, the patient experienced very high blood pressure due to panic attacks, early and heavy period (on day 20 of menstrual cycle), and losing balance. After returning from the hospital on 31-OCT-2021 she had early and heavy period (on day 20 of menstrual cycle), the patient was going through perimenopause but stated that her periods are normally late not early usually on day 25 or 26,28 or 30 (dose number in series 2). On 01-NOV-2021 the patient saw a cardiologist who saw her chart because her blood pressure was measured at the hospital and it was high 162/93 mmHg and told her that panic attacks can raise blood pressure. On an unspecified date, the patient also reported she experienced left arm hurting, the patient specified it as pain at the injection site for which she used ice and it resolved (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chest pain that moved to her back, difficulty breathing, 2 horrible panic attacks, and dizziness on 01-NOV-2021, very high blood pressure due to panic attacks on 31-OCT-2021, felt drunk, and headache on 28-OCT-2021. The event of horrible pain in left arm at injection site resolved on an unspecified date. The outcome of shivers, early and heavy period (on day 20 of menstrual cycle), losing balance and early period was not reported. This report was serious (Other Medically Important Condition). This case, involving the same patient is linked to 20211223061.; Sender's Comments: V0: 20211219942-covid-19 vaccine ad26.cov2.s -chest pain that moved to her back, difficulty breathing, 2 horrible panic attacks, loosing balance, dizziness. 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).