Adverse Effects Associated with the First Dose of the Pfizer–BioNTech COVID-19 Vaccine in Healthcare Workers from Mexico: A Case Serie from Passive Surveillance

Round 1

Reviewer 1 Report

The authors report useful information on passively collected adverse events following the BNT162b2 -vaccine by Pfizer Bio-N-Tech. The reporting is not clear enough and the interpretation goes far beyond the scope of this kind of data presentation.

 

Major

Materials and Methods

1.      It should be more clear in the Methods and the Discussion that the applied 545 doses were all given to health-care workers. These people are more prone to report their symptoms.  

 

Results

2.      Would be beneficial to know characteristics of those vaccinated. Of all of them and not only those with possible AEFI. Health care worker? Age? sex? Morbidities?

 

Discussion

3.       In Discussion, row 193, the authors state: ”Due to the number of cases with a reaction to vaccination, the process must be stopped to guarantee  healthcare for those who required it and continue after the resolution of the previous one.”

a.       When were the doses mentioned in the manuscript given? I presume, during January 2021.

b.        in March 2023  78% of the Mexican population had received their first dose. The data presented in the ms clearly is not adequate to support the authors’ suggestion for stopping vaccinating people. They do not adequately review other literature, or any other, ongoing larger data collections, any data indicating causal relationships, and they do not review any knowledge of the benefits of vaccinating people.

c.        “continue after resolution of the previous one” is not comprehendible and I recommend improving the language.

4.       Row 286 states: ”challenges in graded doses and desensitization have been proposed,

a.       The paragraph should be more careful with suggesting things such as specialist consultation for anyone with any adverse effect

b.       Clearly different approaches for different possible AEFIs need to be recommended.

c.        Since there are several COVID-19 vaccines available and the role of PEG is far from clear, allergen challenges are not to be stated as the option of choice.    

 

Minor

Abstract

5.       In the Abstract and in Introduction the authors state that search for effective tratments started with a one year delay from the start of spread of the disease, which certainly is not true.

6.   

 

Results

9.       Brighton classification for anaphylaxis ref 7 is mentioned in the Methods. This article defines anaphylaxis that can be at three levels of “diagnostic certainty”. The authors need to state, what is “higher level” or “low level” in Results: “According to the Brighton classification, 5 patients (19.23%) were classified as cases with a higher level of certainty of anaphylaxis, 7 (26.92%), with a low level of certainty of anaphylaxis, and 14 (53.85%) as cases that did not meet the definition criteria for anaphylaxis.”

 

10.    Discussion says ”nor did they meet anaphylaxis criteria in the clinical evaluation [27].”

a.      Is this definition different from the Brighton classification in ref 7?

b.      This piece of data belongs to the Methods and Results.

 

11.    How many first doses of other COVID-19 vaccines were given?

12.    the use or non-existent use of epinephrine should be mentioned in the text.

 

Discussion

13.    Possible role of PEG is discussed and it should be more clearly stated that the presented results did not support any of these speculations.

14.    Row 228 states: ”The first adverse effects reported were cutaneous.” without reference. Not clear what data is referred to. (The authors continue and refer to Ref 18)                        .

 

     English should be improved in the Abstract “Within days of the first applications, 0.2% adverse events were reported” row 22 Would be better as: “… adverse events were reported in 0.2% of the vaccinated

Introduction:

7.       ” One of the candidate vaccines that has been surprised…” row 41. Clearly, a vaccine has not been surprised.

8.       Nor can a vaccine produce anything by itself.  (row 44)

15.    Row 230 states: “In a different report about adverse effects, it---”- I suggest the authors mean ”In another report…”. If yes, previous sentence needs editing as well.

 

Author Response

Dear editor and reviewer, 

Thanks a lot for your comments in the file zip it in this comment you will find our response to each comment.

Author Response File: Author Response.pdf

Reviewer 2 Report

1.  The authors have reported a series of cases which developed adverse events after the first dose of BNT162b2 vaccine from Pfizer-BioNTech.  These adverse events occurred 0 to 18 hours after immunization.  Symptoms include hypertensive crises, rash, pruritus, headache, dizziness, and tachycardia.  In addition, two workers had seizures.  The authors have included a table which includes the details of these various cases.  Most cases were woman with a mean age of 33.6 years.  Many had a history of allergies, and some had chronic medical disorders.
2.  They should include information about who evaluated these patients after vaccination and the development of an adverse reaction.  Was it a physician or nurse specialist or who?  Did they use a standardized inventory to record reactions?  It would be helpful if the authors included a table which included a list of allergies, such as the types of foods and drugs.  In addition, a table should include a summary of the adverse reactions to the vaccine. 
3.  The authors suggest that the reactions could have been to an inactive ingredient in the vaccine, such as polyethylene glycol.  Are there well-documented cases of reactions to polyethylene glycol in other situations?
4.  The authors classified the anaphylactic responses and adverse events by the Brighton criteria.  They should probably include some information about these criteria in the Methods.  In addition, they might discuss the Brighton criteria in the discussion section.  When I “googled” these criteria the second article which came up was entitled “We should abandon the Brighton collaboration criteria for a vaccine associated anaphylaxis”.

English is fine

Author Response

Dear reviewer. 

Thanks a lot for your comments. In the file zip it to this comment you can find our response. 

Author Response File: Author Response.pdf