Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rash, Skin abrasion, Tongue ulceration
Clinical narrative: This spontaneous report received from a patient concerned a 46-year-old, female. The patient's height, and weight were not reported. The patient experienced brain inflammation, inflammation of spine and pneumonia when treated with influenza vaccine for prophylactic vaccination many year ago, and drug allergy when treated with ciprofloxacin.  Patient had not taken any flu vaccine since but taken other vaccines with particular no adverse reactions. The patient was not pregnant at the time of vaccination. The patient received COVID-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, expiry: not reported) dose was not reported,1 total, administered on 08-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-MAY-2021, after the vaccination, patient felt dizzy, hence patient kept to the vaccine facility for 45 minutes. On 09-MAY-2021, on next day morning, she felt fine. On same day, she woke up with nausea, fever of 103.9 F, sweating and chills. On 09-MAY-2021, she also had soreness at injection site arm and started developing rash on chest, legs and both arms. She drank lot of water and administered the Tylenol and Advil. Patient took the Tylenol and Advil for first 4-5 days. After administration of Tylenol and Advil, her body temperature was 101 degrees. On 09-MAY-2021, she also had loss of appetite, sores on tongue (Inflamed, red and white) and knees joint pain in first 4-5 days following the vaccination. On 15-MAY-2021, her left side of the face was tingling and numb. She examined herself in mirror and found the left side of face was droopy and patient was drooling. Patient was scared and felt like that was Bell's Palsy. Symptoms disappeared within 18-24 hours. On 16-JUN-2021, patient had a on and off fever (body temperature is 100.9), on and off dizziness, fall because of dizziness, scraping ankle, on and off joint pain, rash, fever blister on lip and face numbness. On 16-Jun-2021, she told that joint pain was much better than when first occurred, rash was only on face and arm at that point and face numbness was much better than when first occurred. On 09-MAY-2021, Laboratory data included: Body temperature (NR: not provided) as 103.9 degrees Fahrenheit. In MAY-2021, Laboratory data included: Body temperature (NR: not provided) as 101 degrees. On 16-JUN-2021, Laboratory data included: Body temperature (NR: not provided) as 100.9 (Units were not reported). Treatment medications (dates unspecified) included: paracetamol, and ibuprofen. The action taken with COVID-19 vaccine ad26.cov2.s was not applicable. The patient recovered from loss of appetite, sweating, chills, injection site soreness, and nausea on 13-MAY-2021, was recovering from left side of face numbness, had not recovered from on and off fever, woozy /dizzy /on and off dizziness, rash on chest, legs, both arms and face, fever blister on lip, sores on tongue, on and off knees joint pain, left side of face tingling, face drooping, face drooling, and tongue inflammation, and the outcome of fall because dizziness and scraping ankle was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210634553-COVID-19 vaccine ad26.cov2.s -Face drooping. 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).