Age: 97.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: her blood pressure was elevated to 190/90 /Blood pressure increased/ high blood pressure; had symptoms like trembling or tremors/ trembly; pains all over her body; feeling weak; headache; had a strong amount of soreness in her injection site; could not thinks too quickly; This is a spontaneous report received from contactable reporter(s) (Nurse) from medical information team. The reporter is the patient.  A 97-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 09Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 97 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: FLU VACCINE VII taken for influenza immunisation as dose number unknown, single. 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. The following information was reported: PAIN (non-serious) with onset 10Oct2023, outcome "recovered" (12Oct2023), described as "pains all over her body"; TREMOR (non-serious) with onset 11Oct2023, outcome "unknown", described as "had symptoms like trembling or tremors/ trembly"; HYPERTENSION (medically significant) with onset 12Oct2023, outcome "recovering", described as "her blood pressure was elevated to 190/90 /Blood pressure increased/ high blood pressure"; BRADYPHRENIA (non-serious) with onset Oct2023, outcome "unknown", described as "could not thinks too quickly"; ASTHENIA (non-serious) with onset Oct2023, outcome "unknown", described as "feeling weak"; VACCINATION SITE PAIN (non-serious) with onset Oct2023, outcome "unknown", described as "had a strong amount of soreness in her injection site"; HEADACHE (non-serious) with onset Oct2023, outcome "unknown". The patient underwent the following laboratory tests and procedures: Blood pressure diastolic: (12Oct2023) the diastolic was around 92; Blood pressure measurement: (12Oct2023) 190/90, notes: on Thursday her blood pressure was elevated to 190/90; (12Oct2023) 192/93, notes: first blood pressure she took was 192/93; (12Oct2023) blood pressure was high, notes: All day yesterday her blood pressure was high. It was in the 180's and 190's,but came down in the evening a little bit; (13Oct2023) 154/72, notes: She took her blood pressure today and thinks it was around 154/72; (Oct2023) 130/72, notes: with medications it runs about 130/72; Blood pressure systolic: (12Oct2023) Systolic was up around 200; Pain assessment: (Oct2023) 6-7 out of 10 on a pain scale. Therapeutic measures were taken as a result of hypertension. Therapeutic measures were not taken as a result of pain. Clinical course: The patient had symptoms like trembling or tremors that started Wednesday, and Thursday her blood pressure was full blown going up. She started out feeling weak, trembly, with a headache, and pains all over her body. It was a different kind of pain like a machine that was going around in her body that would not stop. This was on Tuesday. On Wednesday, she thought there was something wrong with her. On Thursday she took her blood pressure. The first blood pressure she took was 192/93. Systolic was up around 200 and the diastolic was around 92. All day yesterday her blood pressure was high. It was in the 180s and 190s, but came down in the evening a little bit. She talked to her doctor and they said to watch and see what her blood pressure would do. She takes few medications for a few things, but nothing for pain. She bared with the pain, it was there, but was not as bad and gradually went away by Thursday evening. She took her blood pressure and thought it was around 154/72. She said that she could not think too quickly. At the injection site she had no bleeding, but had a strong amount of soreness in her injection site and was a 6-7 out of 10 on a pain scale. Her blood pressure was abnormal for her. She took blood pressure pills and with medications it ran about 130/72. Said that she was scared and it was very serious. She could have had a stroke. She had to call the right people to get help and tell her what to do. she had never had this happen before in her life. She would like her cardiologist to check her.  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 event of Hypertension cannot be excluded. Event considered Related conservatively. There is very limited information provided in this report. Case will be reassessed upon receipt of additional information.