Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Culture, Immune system disorder, Injection site pain, Jaundice, Lymph node pain
Clinical narrative: PAIN IN RIGHT ARMPIT; PAIN IN THE CHEST; COUGHING; MINOR SENSATION IN THROAT LIKE ITCHY; ENLARGEMENT OF EXTRAHEPATIC BILIARY DUCT; JAUNDICE; MUCUSY AND CONGESTION; IMMUNE RESPONSE; PAIN IN  LYMPH NODE; INJECTION SITE STAB; URINARY TRACT INFECTION; SKIN INFECTION; RASH ALL OVER BODY; PUSTULES AND CLUSTERS OF PIMPLE ON FACE; This spontaneous report received from a patient concerned a 71 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: diabetic - insulin, sulfa allergy, arthritis, non smoker, rare alcohol use, contrast dyes allergy, crab/ cantaloupe allergy, preservatives allergy, allergy to statins, and polyethylene glycol 3350 allergy, and other pre-existing medical conditions included: The patient had allergy of electrolytes water including magnesium sulphate. The patient had no drug abuse or illicit drug usage. The patient experienced drug allergy when treated with lidocaine, Novocain (procaine hydrochloride), and Valium (diazepam). She visited an allergist on 19-MAY-2021, before vaccination (2 days before) because she has so many allergies and she was given an Epipen (epinephrine) and prednisone and continued taking it for 2 weeks. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, expiry: UNKNOWN) dose was not reported, 1 total administered on 21-MAY-2021 on left arm for prophylactic vaccination. Concomitant medications included insulin for diabetic-insulin. On 21-MAY-2021, five minutes after receiving her vaccine, developed rash all over her body and had to go to the emergency room where she was given a higher dose of steroid believed to be Prednisone. She stated that the rash lasted for 5 days, it felt like pustules and pimples, she describes it as clusters, but she continued taking her Prednisone. She also took Benadryl and Cortisone 5%. She was coughing and had pain in the chest. She was mucusy and congested. She felt that she also had internal reaction. She had minor sensation in her throat like itchy. When she left the hospital, she went to the gastroenterologist (GI doctor) they found a minor enlargement in the extrahepatic biliary duct, when she left from GI doctor she was all yellow and believed she had Jaundice. Her physician said she probably passed a gall stone. She had magnetic resonance imaging (MRI) a couple of weeks ago and she had a culture done. On JUL-2021, the patient had urinary tract infection and skin infection and was given antibiotics because the culture showed colonization of some bacteria. Laboratory data included: first culture (NR: not provided) colonization of some bacteria, and MRI (NR: not provided) not provided. On 05-AUG-2021, she had another test again and the physician found white blood cells (WBC) in her urine. Laboratory data included: WBC (NR: not provided) WBCs in her urine. She had another culture on 05-AUG-2021 and was still waiting on the results. Laboratory data included: second culture (NR: not provided) results awaited. She still has a pimple on her face but it was 99% resolved. Her issue now was with the pain she feels in her right armpit believed it was her lymph nodes. She described her pain as chronic. She believed that the vaccine might have caused some immune response. She was worried that her vaccine might not be effective because of the steroids she had to take. She felt a stab on the site of injection that lasted for 10 days. Treatment medications (dates unspecified) included: Benadryl (diphenhydramine hydrochloride), cortisone, and prednisone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from rash all over body on 26-MAY-2021, and injection site stab, was recovering from pustules and clusters of pimple on face, had not recovered from pain in right armpit, and pain in lymph node, and the outcome of coughing, minor sensation in throat like itchy, urinary tract infection, skin infection, enlargement of extrahepatic biliary duct, jaundice, pain in the chest, mucusy and congestion and immune response was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000188784. The suspected product quality complaint has been confirmed to be voided (reported complaints were adverse events, hence was confirmed as voided) based on the PQC evaluation/investigation performed.; Sender's Comments: V0: 20210815103-JANSSEN COVID-19 VACCINE Ad26.COV2.S-Rash all over body. This event(s) is labeled per RSI and is therefore considered potentially related.