Age: 92.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Gait disturbance, Immunisation, Off label use
Clinical narrative: Off label use; Booster; unsteady gaits; chest pain; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A 92-year-old male patient received BNT162b2 (BNT162B2), on 12Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 92 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Alzheimer's disease" (unspecified if ongoing); "Fluid retention" (unspecified if ongoing); "Insomnia" (unspecified if ongoing); "Benign prostatic hyperplasia" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: IMMUNISATION (non-serious) with onset 12Apr2022, outcome "unknown", described as "Booster"; OFF LABEL USE (non-serious) with onset 12Apr2022, outcome "unknown"; CHEST PAIN (non-serious) with onset 12Apr2022, outcome "unknown"; GAIT DISTURBANCE (non-serious) with onset 12Apr2022, outcome "unknown", described as "unsteady gaits". The event "unsteady gaits" required physician office visit.  Additional information: Caller asked if there were any reports of patients with chest pain and unsteady gaits following administration of the Pfizer-BioNTech COVID-19 vaccine and also stated that this is definitely good to know and very helpful. NDC number of COVID Vaccine. Pharmacist was informed about the role of Pfizer. Patient's height and weight was unknown. When probed if adverse reaction was for first or second dose: Pharmacist stated that it was for the fourth dose for patient. Time of vaccination was given in vaccination clinic and was between the time of 1:30 and 3:30. Anatomical site of administration was left arm, deltoids, intramuscular. Expiration date was unknown. When probed for lab test details, Pharmacist stated, "Not that I know of." Pharmacist stated, "I'm not sure another experiencing them it was at least 6hours after the vaccination at the facility where they reported them on April 13th 2022." Still experiencing the adverse events: Pharmacist stated, "Unknown." Worsened, improved and persisting (Adverse Event): Pharmacist stated, "Unknown, I don't think they are worsening we heard any reports for worsening." When asked about treatment, 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." Causality: Pharmacists stated, "In my medical opinion I think it's unlikely just because how long after the experiencing reactions and because the unsteady gaits which was reported is not necessary be I 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 you know they are more elderly so unsteady gaits may not be related in my opinion, I say unlikely." This is cross linked with.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.