Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Mental impairment, Pain, Throat tightness
Clinical narrative: Adrenal insufficiency; Brain is not working too well; didn't sleep too well; lots of blood in urine; symptoms of a bladder infection; Severe pain; Blood pressure got so high; booster; dry cough; chest pain; like more of a constriction in my throat too; pretty sick; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 56 year-old female patient received bnt162b2 (BNT162B2), administration date 01Dec2021 (Lot number: FH8030) at the age of 56 years as dose 3, single for covid-19 immunisation. Relevant medical history included: "Ehlers-Danlos syndrome" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "Hashimoto's disease" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing); "Adrenal insufficiency" (unspecified if ongoing); "Coronary vasospasm" (unspecified if ongoing); "disabled" (unspecified if ongoing). Concomitant medication(s) included: RAYOS; LEXAPRO; TYLENOL; ASPIRIN [ACETYLSALICYLIC ACID]; VITAMIN D [ERGOCALCIFEROL]; VITAMIN B12 [CYANOCOBALAMIN]; SPIRONOLACTONE; DHEA; LEVOTHYROXINE; AMLODIPINE; HYDROCORTISONE. Vaccination history included: Covid-19 vaccine (MANUFACTURER UNKNOWN, dose 1, single), for COVID-19 immunisation; Covid-19 vaccine (MANUFACTURER UNKNOWN, dose 2, single). The following information was reported: ADRENAL INSUFFICIENCY (medically significant), outcome "unknown", described as "Adrenal insufficiency"; MENTAL IMPAIRMENT (medically significant), outcome "unknown", described as "Brain is not working too well"; CHEST PAIN (non-serious) with onset 01Dec2021, outcome "unknown", described as "chest pain"; THROAT TIGHTNESS (non-serious) with onset 01Dec2021, outcome "unknown", described as "like more of a constriction in my throat too"; HAEMATURIA (non-serious) with onset 03Dec2021, outcome "unknown", described as "lots of blood in urine"; MALAISE (non-serious) with onset 01Dec2021, outcome "unknown", described as "pretty sick"; CYSTITIS (non-serious) with onset 03Dec2021, outcome "unknown", described as "symptoms of a bladder infection"; COUGH (non-serious) with onset 01Dec2021, outcome "unknown", described as "dry cough"; HYPERTENSION (non-serious) with onset 02Dec2021, outcome "unknown", described as "Blood pressure got so high"; INSOMNIA (non-serious), outcome "unknown", described as "didn't sleep too well"; PAIN (non-serious), outcome "unknown", described as "Severe pain". The patient underwent the following laboratory tests and procedures: blood pressure measurement: high. Therapeutic measures were taken as a result of adrenal insufficiency and included up dose of hydrocortisone; chest pain and included up dose of hydrocortisone, nitrogycerine, and Macrobid; and hypertension and included nitroglycerine.  Clinical course: The patient was just calling for 'assistance' because she had an adverse event from Pfizer before. She had the Pfizer booster on 01Dec2021 and she had chest pain from that within 1 to 2 hours afterwards, and then it kept, it would go away and then come back and she called the cardiologist office on Thursday (as reported) and her blood pressure got so high that she had to take Nitroglycerin (treatment) for her chest pain and high blood pressure from the Pfizer booster. On 05Dec2021 at 2:00 in the morning, she woke up, had lots of blood in urine and had symptoms of a bladder infection from just having had the Pfizer booster on 01Dec2021. She felt pretty sick from this booster that she received. She had to up dose her hydrocortisone with the chest pain after the Pfizer booster and she had to take Nitroglycerine. She takes Amlodipine and she took Macrobid (Intent: treatment). Her brain was not working too well because she didn't sleep too well. She had to take Nitroglycerin on 02Dec2021 with the direction of her cardiologist who was on a call and she normally takes her Amlodipine anyway and she had a up her dose of hydrocortisone because she had adrenal insufficiency. Then on 05Dec2021, she had such severe pain, just blood in urine. So, she have to wait until she sees what the doctors say. If it gets worse, she will have to go to the emergency room.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal association between the events and suspect drug BNT162B2 cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.