Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Investigation, Malaise, Memory impairment, Pain, Pruritus
Clinical narrative: itching; somewhat hoarse; problems talking; Low blood pressure; Hives; syncope; Vomited; C reactive was very high; pain; rash in the back; couldn't sleep; not feeling well; she felt terrible; herpes zoster; she forgot; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 61-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 05Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 61 years intramuscular, in left deltoid for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure" (unspecified if ongoing); "resection of colon", start date: 2003, stop date: 2003; "colon cancer", start date: 2003, stop date: 2003, notes: did not require any chemotherapy. Had colonoscopy that was normal and CA normal. Concomitant medication(s) included: CARVEDILOL; ROSUVASTATIN taken for hypertension. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 4 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 5 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: URTICARIA (hospitalization) with onset 05Oct2023, outcome "unknown", described as "Hives"; HYPOTENSION (hospitalization) with onset 06Oct2023, outcome "unknown", described as "Low blood pressure"; SPEECH DISORDER (hospitalization) with onset 07Oct2023, outcome "unknown", described as "problems talking"; DYSPHONIA (hospitalization) with onset 08Oct2023, outcome "unknown", described as "somewhat hoarse"; VOMITING (non-serious) with onset 10Oct2023, outcome "unknown", described as "Vomited"; C-REACTIVE PROTEIN INCREASED (non-serious) with onset Oct2023, outcome "unknown", described as "C reactive was very high"; SLEEP DISORDER DUE TO A GENERAL MEDICAL CONDITION (non-serious) with onset Oct2023, outcome "unknown", described as "couldn't sleep"; HERPES ZOSTER (non-serious) with onset Oct2023, outcome "unknown"; PRURITUS (hospitalization) with onset Oct2023, outcome "unknown", described as "itching"; MALAISE (non-serious) with onset Oct2023, outcome "unknown", described as "not feeling well"; PAIN (non-serious) with onset Oct2023, outcome "unknown"; RASH (non-serious) with onset Oct2023, outcome "unknown", described as "rash in the back"; FEELING ABNORMAL (non-serious) with onset Oct2023, outcome "unknown", described as "she felt terrible"; MEMORY IMPAIRMENT (non-serious) with onset Oct2023, outcome "unknown", described as "she forgot"; SYNCOPE (hospitalization) with onset Oct2023, outcome "unknown". The patient was hospitalized for urticaria, hypotension, speech disorder, dysphonia, syncope (start date: 10Oct2023, discharge date: 11Oct2023, hospitalization duration: 2 day(s)); for pruritus (start date: 10Oct2023, discharge date: 11Oct2023). The events "hives", "low blood pressure", "problems talking", "somewhat hoarse", "itching" and "syncope" required emergency room visit. The patient underwent the following laboratory tests and procedures: Blood pressure measurement: (06Oct2023) Low; (Oct2023) 80; Colonoscopy: (2023) normal; C-reactive protein: (10Oct2023) 40; (Oct2023) very high; Eosinophil count: (2023) eosinophils were normal; (Oct2023) no eosinophils; Full blood count: (Oct2023) normal; labs: (10Oct2023) all were normal; Red blood cell sedimentation rate: (10Oct2023) Normal; Troponin: (10Oct2023) normal; Urine analysis: (10Oct2023) normal. Therapeutic measures were taken as a result of urticaria, hypotension, speech disorder, dysphonia, pruritus, syncope, rash. Clinical course: Patient had resection of colon because of cancer in 2003 did not require any chemotherapy. Had colonoscopy that was normal and CA normal. His wife received the COVID vaccine 8 days ago. This was the 6th vaccine Pfizer. His wife, after the injection, she developed hives in the lower extremity and then it started getting worse, became hoarse. The next day the hives increased and started having low blood pressure. He took her to withheld and seen. Was treated with epinephrine for syncope. Started on Benadryl 50mg q 6 hours. Was discharged 2 days ago. When got home she got worse and started developing more hives and now he took her to withheld emergency. The service was bad and he took her home and gave epinephrine. Epinephrine turned out more. Got Decadron at withheld. He did not know what to expect. Her C reactive was very high, CBC was normal, no eosinophils. This was terrible. He had been taking pictures of the hives and everything. she (patient) was pediatrician in her country. He had been functioning as her primary. When went to withheld he mentioned and gave that history but had not reported to Pfizer. Got vaccine in the morning and 2 hours or 4 hours or something after she developed some hives in her knee. Started not feeling well. Complained of some itching and then started having problems talking. She became somewhat hoarse. The next day on Sunday, she woke up and she was hoarse. Trouble talking a little Saturday, but not much. hives outcome: this morning was awful, all her body. Saw after being discharged from withheld thought following recommendation would be fine. Last night she felt terrible with a lot of pain because of the rash in the back it was like herpes zoster. She couldn't stand it, she was moving and couldn't sleep. The other thing when he decided to take her to withheld was because when he got home he noticed some vomit in the bathroom, and she didn't recall. He asked and she forgot. Vomited Tuesday 10Oct2023. Admitted to hospital 10Oct2023. Discharged after 24 hours on 11Oct2023. She was with hives. Low blood pressure was the day after the vaccine. outcome: this morning was 80 and he took to ER knowing ER withheld did not think they have much experience. She was getting worse waiting so he decided to take her to home and inject epinephrine. seriousness hives: he had pictures that he took. States for seriousness hospitalization for all. Before taking to withheld he ordered some labs and all were normal except CRP that was 40 on 10Oct2023. Suspect Product: When queried formulation or color cap caller states it was the New Pfizer COVID vaccine. Got at withheld. Did not have NDC lot or expiry to provide. Carvedilol - Initially prescribed for high blood pressure but cardiologist gave very high dose and decreased it because she was having hypotension. Investigation: at the hospital her troponin was high, not much, it was 7 on 10Oct2023. But then they checked and told him it was normal. They had a case of patient that developed eosinophilic carditis and died so he was concerned. States her eosinophils were normal. Caller was seeing patients that time and was not able to complete supplemental form.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: Based on the limited information provided in this case, a contributory role of the suspect product BNT162b2 (COMIRNATY) to the reported events cannot be excluded. Events are considered Related conservatively. There is very limited information provided in this report. Case will be reassessed upon receipt of additional information.,Linked Report(s) : US-PFIZER INC-202300329877 Same patient, different drug and event;