Age: 83.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Diarrhoea, Diarrhoea haemorrhagic, Flatulence, Full blood count normal, Nausea
Clinical narrative: nauseas, threw up twice, not much; nauseas, threw up twice, not much; Diarrhea/loose stool/turned into watery; Site of injection bled a lot; injection site was just a little sore; slight dry, sore throat; slight dry, sore throat; Diarrhea has subsided some now, is more kind of bloody discharge. Did have history hemorrhoids; This is a spontaneous report received from a Consumer or other non HCP.  An 83-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 05Sep2024 as dose 1, single (Lot number: LM2215, Expiration Date: 15Mar2025) at the age of 83 years, in right deltoid for covid-19 immunisation. The patient's relevant medical history included: "Pneumonia", start date: Jul2024 (unspecified if ongoing), notes: a month ago; post pneumonia coughing; hospitalized; "Hiatal hernia" (unspecified if ongoing); "post pneumonia coughing" (unspecified if ongoing); "hemorrhoids" (unspecified if ongoing); "breast cancer" (unspecified if ongoing), notes: 25 years ago; "hospitalized" (unspecified if ongoing), notes: for pneumonia. Concomitant medication(s) included: TRELEGY ELLIPTA taken for pneumonia; PANTOPRAZOLE SODIUM DELAYED RELEASE taken for hiatus hernia, start date: 16Aug2024. The patient also took other concomitant therapy. Past drug history included: Azithromycin, notes: 4 days; a month ago. Vaccination history included: BNT162b2 (Dose 1; Batch/Lot number: EN6203, right arm), administration date: 01Mar2021, when the patient was 79-year-old, for Covid-19 immunization, reaction(s): "Vaccination site pain"; BNT162b2 (Dose 2; Batch/Lot number: ER8727, right arm), administration date: 23Mar2021, when the patient was 79-year-old, for Covid-19 immunization, reaction(s): "Vaccination site pain"; BNT162b2 (Dose 3; Batch/Lot number: FH8027, right arm), administration date: 09Nov2021, when the patient was 80-year-old, for Covid-19 immunization, reaction(s): "Vaccination site pain"; BNT162b2, BNT162b2 omi ba.4-5 (Dose 5; Batch/Lot number: GJ6738, right arm,  Intramuscular), administration date: 02Dec2022, when the patient was 81-year-old, for Covid-19 immunization, reaction(s): "Vaccination site pain"; BNT162b2 (Dose 4; Batch/Lot number: FK9893, right arm), administration date: 21Apr2022, when the patient was 80-year-old, for Covid-19 immunization; comirnaty (2023-2024 formula) (Dose 6; Batch/Lot number: HG4664, right arm), administration date: 19Oct2023, when the patient was 82-year-old, for Covid-19 immunization, reaction(s): "Vaccination site pain", "Pneumonia". The following information was reported: HAEMORRHOIDAL HAEMORRHAGE (non-serious) with onset 2024, outcome "unknown", described as "Diarrhea has subsided some now, is more kind of bloody discharge. Did have history hemorrhoids"; VACCINATION SITE HAEMORRHAGE (non-serious) with onset 05Sep2024, outcome "unknown", described as "Site of injection bled a lot"; VACCINATION SITE PAIN (non-serious) with onset 05Sep2024, outcome "unknown", described as "injection site was just a little sore"; DRY THROAT (non-serious), OROPHARYNGEAL PAIN (non-serious) all with onset 05Sep2024, outcome "not recovered" and all described as "slight dry, sore throat"; DIARRHOEA (non-serious) with onset 06Sep2024, outcome "recovering", described as "Diarrhea/loose stool/turned into watery"; NAUSEA (non-serious) with onset 06Sep2024 at 04:00, outcome "recovered" (2024), VOMITING (non-serious) with onset 06Sep2024 at 04:00, outcome "unknown" and all described as "nauseas, threw up twice, not much". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of vaccination site haemorrhage. Additional information: Patienr got vaccine yesterday at noon, has had extreme reaction to it. Patient has had all the other Covid shots, vaccines and boosters, never had reaction at all, it is the new formula.Site of injection bled a lot, more than she expected, it ran down her arm. Patient was in the hospital, a month ago, for pneumonia, they gave her shots daily, so she would not get blood clots. By evening, injection site was just a little sore , which is typical from previous Covid shots, did not think anything of that. Patient had very slight dry sore throat by the time she went to bed. At 4AM, woke up nauseas, threw up twice, not much, because it was 4AM. Patient had diarrhea, started as loose stool, turned into watery, from everything inside her.  Site of injection bled a lot happened after injection, yesterday, 5Sep2024. It ran down her arm and, pharmacist had to clean it up, put band aid on it. 2 hours after that, took Band-aid off, did not have a mark. Slight dry, sore throat was by yesterday evening, 5Sep2024, had slight dry, sore throat. Patient was taking medications, a couple new medications, as follow up from pneumonia, end of Jul2024. 2 are new, up until yesterday. Patient  has not taken anything today. Had no adverse reactions from any of that. Outcome of event Slight dry, sore throat was still kind of there, throat is very dry. Has stayed about the same. Diarrhea has subsided some now, is more kind of bloody discharge. Did have history hemorrhoids.  There is nothing much to come out anymore. It is uncontrollable liquid. Pantoprazole Sod DR is antacid for large hiatal hernia, she has had for long time. Thinking that may have inhibited her recovery from pneumonia because, it is same side as left. Had pneumonia, doctor wanted her to take something stronger for that. Medical conditions included just the pneumonia, was in hospital 4 days, end of Jul2024.  Test results indluded CT scan, 1 in hospital, had another one on just a few days ago, 20Aug2024.All previous Covid-19 vaccines were Pfizer. Anatomical Site of injection would have all been in right arm, does not get anything in left arm because of breast cancer, 25 years ago. Patient was on  IV  antibiotics in hospital and, 4 days of Azithromycin in pill form when at home. When patient had the antibiotics and Azithromycin in pill form, it was not within 2 weeks of reaction from Covid-19 vaccine. Was a month ago. Patient has been trying to drink a little water. Patient does not have nausea anymore but, has not had anything to eat. Additional Information for other medicines Trelegy Ellipta included 200mcg/62.5mcg/25mcg, Does not names of drugs in Trelegy Ellipta.Not inhaler, is flat disc thing. Has been taking 22 days. Has helped tremendously with post pneumonia coughing and mucus symptoms.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400252210 Same patient, different event/Vaccine;US-PFIZER INC-202400252207 Same patient and drug, similar event, different dose;US-PFIZER INC-202400252211 Same patient and drug, similar event, different dose;US-PFIZER INC-202400252212 Same patient and drug, similar event, different dose;US-PFIZER INC-202400252208 Same patient and drug, similar event, different dose;US-PFIZER INC-202400252209 Same patient and drug, similar event, different dose;