Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Immobile, Injection site pain, Nausea, Pain, Paraesthesia oral
Clinical narrative: LOSS OF MOBILITY; FLUSHING TO FACE(RED); PUFFY FACE; DIZZINESS; TROUBLE EATING; GENERAL FEELING OF ACHINESS; A COUPLE OF WELTS ON LEFT FOREARM AND 2-3 ON BACK IN THE LEFT SHOULDER AREA; NAUSEA; VERY INTENSE HEADACHES; INJECTION SITE SORENESS; DIARRHEA; TINGLING SENSATION ON TONGUE; FEVER; This spontaneous report received from a patient concerned a 69-year-old female ethnicity. The patient's weight was 191 pounds, and height was 63 centimeters. The patient's past medical history included: possible covid infection, pneumonia, flu felt like a serious case of the flu at experienced at age 13 and concurrent conditions included: mitral valve prolapse, hypothyroidism, penicillin allergy, egg allergy(yolk and egg white), gluten allergy, tomato allergy, oatmeal allergy, nuts allergy( macadamia, walnuts, hazelnuts, peanuts), multiple esophageal polyps, esophagitis, duodenitis, multiple polyps in stomach, and asthma, and other pre-existing medical conditions included: The patient had a history of diary products allergy. The patient experienced drug allergy when treated with ethanol, etomidate, and atenolol. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, expiry: 09-JUN-2021) dose was not reported,1 total administered on 27-MAR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported.  On 27-MAR-2021, about 30 minutes after the injection the patient experienced started having a tingling sensation on her tongue, and immediately took Benadryl (patient has extensive history of allergic reactions and a tingling sensation on her tongue in the past has been a signal that she is about to have an allergic reaction), patient stated that she carried on taking the Benadryl every 4.5 -5 hours for the next two days: 28-MAR-2021 and 29-MAR-2021 for the allergic reactions she was experiencing, flushing to face (red), puffy face, loss of mobility and had spent a lot of time from the date of vaccination 27-MAR-2021 to 04-APR-2021 in bed, dizziness, trouble eating, general feeling of achiness, a couple of welts on left forearm and 2-3 on back in the left shoulder area and felt that the Benadryl helped her welts as they went down after she took the Benadryl but returned when she was due for another dose of Benadryl, nausea, very intense headaches which she continued to suffer from for up to 3 months after she received the vaccine. She also said that she is still experiencing headaches on occasion which is not normal for her, injection site soreness, diarrhea, within 1-2 hours of receiving the vaccine the patient experienced fever, for which tylenol was taken and patient claimed it helped her and fever lasted for 2 days. Laboratory data included: Fever (NR: not provided) 101.3 deg. Treatment medications included: diphenhydramine hydrochloride, paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from loss of mobility, and trouble eating on 01-APR-2021, flushing to face(red), puffy face, dizziness, nausea, injection site soreness, diarrhea, and tingling sensation on tongue, and fever on 29-MAR-2021, had not recovered from a couple of welts on left forearm and 2-3 on back in the left shoulder area, and very intense headaches, and the outcome of general feeling of achiness was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: 20211061515-covid-19 vaccine ad26.cov2.s-Loss of mobility. 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).