Sex: F
Vaccine: COVID19
Symptoms: Ear disorder, Fatigue, Feeling abnormal, Fibrin D dimer, Gait disturbance
Clinical narrative: SUSPICION OF FLUID LEAK INTO EARS; DECREASED LUNG FUNCTION; LOSS OF PERIPHERAL VISION; NUMB LEGS; DIFFICULTY WALKING ACROSS THE ROOM/UNSTEADY GAIT; DIARRHEA; SHORTNESS OF BREATH; EXTREME VERTIGO; WEAK LEGS; HEADACHE/OCCIPITAL HEADACHE; ARTHRALGIA; SORE ARMS; MYALGIA; FATIGUE; FOGGY HEADED; ANAPHYLAXIS; FEVER; This spontaneous report received from a physician concerned a 30-year-old patient The patient's height, and weight were not reported. The patient's concurrent conditions included attention deficit hyperactivity disorder (ADHD), asthma, and milk allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration was not reported, batch number and expiry date were unknown) dose was not reported, 1 total, administered on left arm on 10-APR-2021 for prophylactic vaccination. The batch number was not reported has been requested. No concomitant medications were reported.  On 10-APR-2021, within 30 minutes of vaccination, the patient developed anaphylaxis with no airway compromise, hives, swelling of limbs, face and administration site. The patient could not get immediate treatment for about an hour and then received Benadryl (diphenhydramine hydrochloride). On an unspecified date, in APR-2021, the patient experienced fever with a temperature of 100s (unit not provided). On 11-APR-2021, the hives started to go down with Benadryl treatment but it was not completely gone. On the same day, the patient experienced headache/occipital headache, arthralgia, sore arms, myalgia, fatigue and was foggy headed. On 12-APR-2021, the patient experienced shortness of breath, difficulty walking across the room (unsteady gait), extreme vertigo, diarrhea, numbness of legs and weakness of legs. It seemed like the patient was exhibiting symptoms of coronavirus disease (COVID-19). On 14-APR-2021, she eventually went to the emergency room (ER). The patient was tested for COVID-19 (swab test) and titres but both were negative. On an unspecified date, in APR-2021 (within 5 days of start of symptoms), a magnetic resonance imaging (MRI) without contrast was done and it did not show any blood clot, and D-dimer test was negative. The physician suspected a fluid leakage into the patient's ear and wanted to know if adenovirus from vaccine could be implicated. The patient was prescribed meclizine, but it did not help. On an unspecified date, a pulmonary function test (PFT) was done which showed decreased lung function. The patient also had steroid (unspecified) for 4 days. On an unspecified date, in MAY-2021 (about 8 days before report), the patient started to lose peripheral vision and her vertigo escalated. It was reported that the patient was due for an MRI on 12-MAY-2021. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sore arms, fatigue, foggy headed, myalgia, arthralgia, shortness of breath, difficulty walking across the room/unsteady gait, extreme vertigo, diarrhea, weak legs, fever, headache/occipital headache, loss of peripheral vision, anaphylaxis, numb legs, suspicion of fluid leak into ears and decreased lung function was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210520835-COVID-19 VACCINE AD26.COV2.S-Anaphylaxis. This event(s) is labeled and is therefore considered potentially related.