Adverse Event Reporting
|Number of vaccinations||1|
- Pain in extremity
Medical History/Concurrent Conditions: Allergy; Asthma; Blood cholesterol abnormal; Blood pressure high; Diabetes; Post procedural pain; Reflux gastritis; Rosacea; Sciatica; Shingles; Sinus congestion; Swelling
; HCTZ; ; ; ; ; ; ; ZYRTEC [CETIRIZINE HYDROCHLORIDE]; ; VITAMINS [ASCORBIC ACID;ERGOCALCIFEROL;NICOTINAMIDE;RETINOL;RIBOFLAVIN;THIAMINE HYDROCHLORIDE];
she is better but still not good; not to be able to breath; sore right arm; This is a spontaneous report from a contactable nurse (patient herself).
A 62-year-old female patient received bnt162b2 (BNT162B2, lot EK5730), intramuscular on 18Dec2020 at single dose for immunisation.
Medical history included asthma (hospitalized on Jan2020 and has not had any issues since that time, referring to her asthma) diabetes, high blood pressure, swelling, sciatica, blood cholesterol abnormal, rosacea, reflux, allergies, sinus congestion, shingles and post carpal tunnel surgery.
Concomitant medications included lisinopril, hydrochlorothiazide, gabapentin, rosuvastatin, metformin, glipizide, doxycycline, sucralfate, cetirizine hydrochloride (ZYRTEC), pseudoephedrine, ascorbic acid, ergocalciferol, nicotinamide, retinol, riboflavin, thiamine hydrochloride (VITAMINS) and tramadol.
The patient reported that she not to be able to breath (seriousness criteria-life threatening) on 22Dec2020.
She woke up this morning and could not breathe and there was no reason for her to not be able to breath.
She thought she may have had a reaction to the COVID vaccine.
It was the only thing she could think of that might have caused her not to be able to breathe this morning.
As treatment for not to be able to breath, she used Budesonide and Levosalbutamol in her nebulizer.
She had sore right arm on 18Dec2020.
She informed that she had done everything she can and she was better but still not good.
She planned to take the second dose of the COVID Vaccine because she thought it was more important to be protected.
She suspected that the vaccine was related to the events sore right arm and could not breathe.
The outcome of the event not to be able to breath was recovering; for sore right arm was recovered on unknown date in Dec2020; for she is better but still not good was unknown.
; Sender's Comments: Severe allergic reaction including anaphylaxis is the known risk factor; a possible causal association between administration of BNT162B2 and the onset of not being able to breath cannot be excluded, considering the plausible temporal relationship and the known adverse event profile of the suspect product.
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.