Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Breath holding, Chest discomfort, Chest pain, Dyspnoea, Echocardiogram
Clinical narrative: The initial safety information received was reporting only non-serious adverse drug reactions, Upon receipt of follow-up information on 31Jan2022, this case now contains serious adverse reactions. Information processed together. This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Other HCP). The reporter is the patient. A 44 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in deltoid left, administration date 13Dec2021 09:30 (Lot number: FD0809) at the age of 44 years as dose 1, single for Covid-19 immunisation. Relevant medical history included: "achalasia" (unspecified if ongoing); "GERD" (ongoing); "fatty liver" (unspecified if ongoing); "penicillin" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing), notes: Medicine controlled high blood pressure; "Hypertension" (ongoing); "Anxiety" (ongoing); "Thyroid goiter" (ongoing); " Gestational diabetes mellitus", stop date: 2011. Family history included: "Hypertension" (unspecified if ongoing), notes: Father; "Type 2 diabetes mellitus" (unspecified if ongoing), notes: Father. Concomitant medication(s) included: LABETALOL taken for hypertension, anxiety (ongoing); PREVACID; LANSOPRAZOLE taken for gastrooesophageal reflux disease (ongoing). Past drug history included: Codeine, reaction(s): "Drug allergy"; Morphine, reaction(s): "Drug allergy"; Sulfates, reaction(s): "Drug allergy"; Amoxicillin, reaction(s): "Drug allergy". Patient did not receive other vaccine in four weeks prior to the COVID vaccine. Patient had no COVID prior vaccination. The following information was reported: PALPITATIONS (hospitalization) with onset 15Dec2021, outcome "recovering", described as "Palpitation"; DYSPNOEA (hospitalization) with onset 15Dec2021, outcome "recovering", described as "Shortness of breath"; HEART RATE INCREASED (non-serious) with onset 14Dec2021 09:00, outcome "not recovered", described as "Rapid heart rate"; CHEST PAIN (non-serious), CHEST DISCOMFORT (non-serious) all with onset 14Dec2021 09:00, outcome "not recovered" and all described as "chest pressure and pain". The events "palpitation", "shortness of breath", "rapid heart rate", "chest pressure and pain" and "chest pressure and pain" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: breath holding: (12Dec2021) 0.993; echocardiogram: (unspecified date) scheduled; full blood count: (12Dec2021) within normal limits; glycosylated haemoglobin: (12Dec2021) 6.1; heart rate: (14Dec2021) rapid; metabolic function test: (12Dec2021) elevated LFTS (Liver function test), notes: Stable for patient. Therapeutic measures were not taken as a result of palpitations, dyspnoea. It was unknown if therapeutic measures were taken as a result of heart rate increased, chest pain, chest discomfort. Clinical course: No COVID tested post vaccination. The other health care professional confirmed that patient provided information regarding the reported events and considered that suspect product had a causal effect to the adverse events. Sender's Comments: Based on available information and the drug temporal relationship, the causality between the events - Palpitations, dyspnea, and the suspect drug "BNT162B2" cannot be completely 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.