Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Pain, Pyrexia, SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: GALLBLADDER INFECTION (CHOLECYSTITIS); CHOLECYSTITIS INFECTIVE; BLOOD CLOT THATS ON THE TOP OF LIVER (THROMBOSIS); ANTICOAGULANT THERAPY; COVID-19 INFECTION; COLOSTOMY; INFECTION; SARS-COV-2 TEST POSITIVE; SUSPECTED CLINICAL VACCINATION FAILURE; BLOOD TEST ABNORMAL; PAIN; FEELING COLD; MALAISE; VOMITING; PYREXIA; BAD CASE OF ACID REFLUX (GASTROOESOPHAGEAL REFLUX DISEASE); This spontaneous report received from a health care professional via a Regulatory Authority Vaccine Adverse Event Reporting System (VAERS) (VAER reference number 1582450) concerned a 63 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient experienced drug allergy when treated with codeine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: UNKNOWN) dose was not reported, 1 total administered to right arm on 03-JUL-2021 at 12:43 PM for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included ascorbic acid/ergocalciferol/folic acid/retinol/tocopherol/vitamin. On 19-JUL-2021, the patient woke up at 5:30 am with a bad case of acid reflux which he had a while ago but not since he was taking prebiotics and probiotics which helped but not this time. He was vomiting and had a fever. He took Omeprazole that morning which has relieved it for a while but after eating some food it started all over again. The vomiting and fever was back with higher severity than before. By Wednesday, on 28-JUL-2021, it was better bad so he went over to a Medical Center for COVID-19 test which was was negative. They did ran a battery of blood work on him but after waiting for five long hours to be seen by a doctor he was extremely cold in the waiting area and he was in great pain sitting on the uncomfortable chairs. On 29-Jul-2021, The patient went over to urgent care and once again the PA give him another COVID- 19 test which was negative. The PA suggested the patient to visit over to a Hospital. On 30-Jul-2021, the patient went over there was tested again and was negative again. They checked him in but they never found the Covid-19 after being poked and stuck so many times he was really not feeling good and they did know that he had a inflamed and infected gallbladder which the infection traveled through his blood stream Which was very dangerous for him however it app eared that they were taking his blood every two hours which became very unbearable for him and he wanted to go home I went to pick him up at 3:00 am One of the call me to convince to still in the hospital but he refused. On 31-Jul-2021, the patient went over to another Hospital COVID test where he was found positive. The patient was diagnosed with COVID-19 infection (suspected clinical vaccination failure). All because his gallbladder was very inflamed and infected due to the vaccine and he also has a blood clot that was on top of his liver. The patient had to wear a colonoscopy bag until they can remove his gallbladder which was about four weeks. He had to wear the bag to drain any infection. He also administered with blood thinner (anticoagulant therapy). On an unspecified date, the patient was admitted to hospital. The patient was hospitalized for 7 days.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from anticoagulant therapy, blood test abnormal, covid-19 infection, gallbladder infection (cholecystitis), cholecystitis infective, colostomy, feeling cold, bad case of acid reflux (gastrooesophageal reflux disease), infection, malaise, pain, pyrexia, sars-cov-2 test positive, blood clot thats on the top of liver (thrombosis), and vomiting, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Hospitalization Caused / Prolonged). This report was associated with product quality complaint : 90000191544 The suspected product quality complaint has been confirmed to be the reported allegation could not be confirmed. A manufacturing related root cause could not be identified. Based on the Regulatory Authority evaluation/investigation performed.  Additional information was received from Complaint Vigilance on 23-SEP-2021. The following information was updated and incorporated into the case narrative: product quality complaint investigation results added.; Sender's Comments: V2: Additional information received updates: Product quality complaint investigation results added. This added information does not alter the causality of prior assessed events.  20210857180- COVID-19 VACCINE AD26.COV2.S-gallbladder infection (cholecystitis), cholecystitis infective,  blood clot thats on the top of liver (thrombosis), covid-19 infection, bad case of acid reflux (gastrooesophageal reflux disease), sars-cov-2 test positive, colostomy, infection, pain, anticoagulant therapy, blood test abnormal. 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). 20210857180- COVID-19 VACCINE AD26.COV2.S-feeling cold, malaise, pyrexia, vomiting. This event(s) is labeled per Regulatory Authority and is therefore considered potentially related. 20210857180- COVID-19 VACCINE AD26.COV2.S-suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS