Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Balance disorder, Body temperature, Chest discomfort, Dyspnoea, Echocardiogram
Clinical narrative: numbness in both hands and feet; Brain fog; Equilibrium issues; flu-like symptoms; Fever; severe headache; migraine; throat was itchy; itchy under my skin in arms; Chest tightness; difficulty breathing (without wheeze or stridor); respiratory distress; inflammation; tachycardia; Heart palpitations; nausea; The initial safety information received was reporting only non-serious adverse drug reactions. Upon receipt of follow-up information on 12Nov2021, this case now contains serious adverse reactions. Information processed together.  This is a spontaneous report from a contactable healthcare professional (patient). A 43-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: FF2589), via an unspecified route of administration in left arm on 29Sep2021 at 12:00 (at the age of 43-years-old) at dose 1, single for COVID-19 immunisation. Medical history included multiple sclerosis and penicillin allergy. She then mentioned that she was not fully diagnosed with prior COVID infection, but her antibodies in blood test came up positive on an unspecified date. Concomitant medications included vitamin B NOS (VITAMIN B), vitamin D NOS (VITAMIN D), and biotin. Vaccination facility type was reported as pharmacy or drug store. On 29Sep2021 at 12:10, about 10 minutes after vaccination, the patient's throat became itchy then she felt itchiness under the skin in her arms. Chest tightness came later that night (29Sep2021), respiratory distress and difficulty breathing (without wheeze or stridor) were also reported. The next day, on 30Sep2021, she had flu-like symptoms, fever at 101, severe headache, and migraine. The following day, on 01Oct2021, she had numbness in both hands and feet, then brain fog/ equilibrium issues started. The patient also experienced inflammation, tachycardia, heart palpitations, and nausea, all from an unspecified date in 2021. An MRI brain was performed on 07Oct2021 to check for new lesions (2021). Multiple organ involvement was reported as cardiovascular with symptoms stated as tachycardia and heart palpitations. There was no measured hypotension, shock, capillary refill time less than 3 seconds, reduced central pulse volume, decreased level of consciousness, loss of consciousness, or other symptoms. For respiratory involvement, symptoms included chest tightness, respiratory distress, and difficulty breathing (without wheeze or stridor). There was no bilateral wheeze/bronchospasm, stridor, upper airway swelling, tachypnoea, increased use of accessory respiratory muscles, recession, cyanosis, grunting, dry cough, hoarse voice, sensation of throat closure, sneezing, rhinorrhea, or other symptoms. There was no dermatological/ mucosal involvement. She had no symptoms of generalized urticaria, generalized erythema, angioedema (not hereditary), generalized pruritus with skin rash, generalized pruritus without skin rash, generalized prickle sensation, localized injection site urticaria, red and itchy eyes, or other symptoms. For gastrointestinal involvement, nausea from equilibrium/balance/ brain fog issues was reported. There was no diarrhea, abdominal pain, vomiting, or other symptoms. The events required emergency room/department or urgent care and doctor and other healthcare professional office/clinic visit. She went to urgent care who referred her to her multiple sclerosis doctor. She was not hospitalized or admitted to an intensive care unit. Therapeutic measures were taken as a result of all events which included treatment with prednisone. It was also reported that prednisone was used for numbness and inflammation, BENADRYL for itching, and TYLENOL for fever, headache, and flu-like symptoms. The patient underwent lab tests and procedures which included temperature: 101 on 30Sep2021, ECHO: unknown result on 18Oct2021, EKG: unknown result on an unspecified date in 2021, MRI brain to check for new lesions: unknown result on 07Oct2021, MRI spine cervical: unknown result on 08Oct2021, COVID-19 antibody test: positive on an unspecified date, and COVID-19 test via nasal swab: negative on 01Oct2021. She did not receive any recent vaccines for any other conditions prior to the events being reported. She did not receive any recent vaccines for SARS-CoV2 other than Pfizer-BioNTech COVID-19 Vaccine prior events being reported. She did not receive any other vaccine around the Pfizer BioNTech COVID-19 vaccine vaccination. The outcome of the events was not recovered.; Sender's Comments: As there is limited information in the case provided, the causal association between the events throat became itchy, itchiness under the skin in her arms, chest tightness, respiratory distress, difficulty breathing, flu-like symptoms, fever at 101, severe headache, migraine, numbness in both hands and feet, brain fog, equilibrium issues, inflammation, tachycardia, heart palpitations and nausea and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.