Age: 89.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Gait disturbance, Investigation
Clinical narrative: Chest pain; Unsteady gait; The initial case was missing the following minimum criteria: Unspecified AE. Upon receipt of follow-up information on [14Apr2022], this case now contains all required information to be considered valid.  This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  An 89-year-old male patient received BNT162b2 (BNT162B2), on 12Apr2022 as dose 4 (booster), single (Lot number: FK9896) at the age of 89 years intramuscular, in left deltoid for covid-19 immunization. The patient's relevant medical history included: "Type 2 diabetes" (unspecified if ongoing); "Vitamin D deficiency" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "Hyperlipidemia" (unspecified if ongoing); "Falls" (unspecified if ongoing), notes: the patients who did that have a history of falls. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (First dose, MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (Second dose, MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (Third dose, MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: CHEST PAIN (hospitalization) with onset 13Apr2022, outcome "unknown"; GAIT DISTURBANCE (hospitalization) with onset 13Apr2022, outcome "unknown", described as "Unsteady gait". The events "chest pain" and "unsteady gait" required physician office visit. The patient underwent the following laboratory tests and procedures: To get test: (Apr2022) Unknown Results. Therapeutic measures were taken as a result of chest pain, gait disturbance. Clinical course was reported as, Reporter (Pharmacist) states, we had 5 patients with adverse events, all presented these events 6 hours following vaccination with the Pfizer-BioNTech COVID-19 vaccine. The first patient (Patient 1: Female, 89 years old) had a cardiovascular event that lead to death. On the 4 other patients, they are all over 80 years of age. One patient (Patient 2) experienced chest pain and unsteady gaits and other patient (Patient 3) experienced swelling in the face. And asks what is the prevalence of cardiovascular events leading to death following vaccination. Pharmacist called to report a possible adverse reactions to the Pfizer COVID vaccine and then also wanted to follow-up with 5 more reports (later pharmacist clarified that there were only 4 patients so, 4 reports were filed, This case is for Patient 4) with potential reactions to the Pfizer COVID vaccine. Reported that, Vaccine was given in vaccination clinic and time of vaccination was between the time of 1:30 and 3:30. Pharmacist don't know for any of patient really and not aware of any lab test they might have undergone recently. Pharmacist stated, for (name initial withheld) reported experiencing swelling in the face and then for the other three patients they reported chest pain and unsteady gait. Reporter was not sure another experiencing them and start date of adverse events was at least 6hours after the vaccination at the facility where they reported them on 13Apr2022 and stated don't think they are worsening not heard any reports for worsening. Pharmacist stated, They did well it was reported by the facility that they were taken to the hospital to get look at another word what treatment they might receive. That's what were reported to us that they were taken for the hospital to get test, yes that's what we were told and reported in medical opinion reporter think it's unlikely just because how long after the experiencing reactions and because the unsteady gaits which was reported is not necessary be, and don't think actually report unsteady gaits haven't see in fact either all of the patients who did that have a history of falls and know they are more elderly so unsteady gaits may not be related in reporter's opinion, says unlikely.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine cannot be excluded for the reported events of Chest pain and Unsteady gait due to temporal relationship.   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.