Successful administration of second dose of BNT162b2 COVID‐19 vaccine in two patients with potential anaphylaxis to first dose

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Allergy. 2022;77:337–338.
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337wileyonlinelibrary.com/journal/all
Received: 30 March 2021
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Revised: 6 June 2021
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Accepted: 28 June 2021
DOI: 10.1111/all.14996
CORRESPONDENCE
Successful administration of second dose of BNT162b2
COVID- 19 vaccine in two patients with potential anaphylaxis
to first dose
Dear Editor,
We read with interest the discussion by Cabanillas et al on
polyethylene glycol (PEG) as a hidden allergen in the BNT162b2
COVID- 19 vaccine.1
We were referred t wo female patients in December 2020, who
reacted within minutes of vaccination. Patient 1 was 53 years old
with no anaphylaxis history. Patient 2 was 35 years old with well-
controlled asthma, with previous anaphylaxis to shellfish and con-
trast media. We performed allergy testing to PEG3350 and the
vaccine itself. Second doses were successfully administered via
graded dosing.
Five minutes after her first vaccination, Patient 1 experienced
light- headedness, prickling to lips and mouth, chest tightness, fa-
cial flushing, palpitations, and sudden tenesmus. She remained
normotensive. Nursing documented facial erythema, lip swelling,
angioedema, dif ficulty breathing, throat tightness, and a feeling of
dread. The patient disputed throat tightness or angioedema 5 days
later. A code blue was called. Her symptoms rapidly improved with
0.5 mg of IM epinephrine and IV fluids.
Patient 2 experienced throat tightness, mild mouth itching,
profound weakness, shortness of breath, and difficulty breathing
2– 3 minutes following vaccination. Nursing records indicated an-
gioedema. A code blue was called. No vitals were taken. Epinephrine
0.5 mg IM was administered. She was transferred to emergency (ER)
and experienced a second wave of shortness of breath, throat tight-
ness, and documented wheeze. Salbutamol, methylprednisolone,
and diphenhydramine were administered, with improvement.
Both patients were referred for urgent allergy assessment. Skin
testing to PEG3350 two weeks after initial reaction was negative.
Patient 2 was oral challenged to PEG3350 without reaction. Neither
patients had known PEG allergy. Literature on PEG allergies suggests
that tolerating higher molecular weight formulations implies toler-
ance to lower molecular weight formulations.2 Accordingly, it was
reassuring our patients tolerated PEG3350, suggesting they would
tolerate the PEG20 00 in the vaccine.2,3 That said, more recent work
suggests skin testing to native PEG may be falsely negative. Testing
to PEGylated liposomes, which more closely resemble PEG in the
vaccine, may improve sensitivit y.4
We obtained vaccine that would otherwise be discarded (rem-
nants), for skin testing. Skin testing at full strength was completed
without reaction. Intradermal testing to dilute (1:10) and full-
concentration (1:1) vaccine was also negative. A healthy control con-
firmed no irritation to the vaccine.
As there were no reports of administering second doses to
high- risk patients, we administered second doses in the ER using a
graded dosing regimen (Table 1), following previously described pro-
tocols.5 The regimen used 0.05 mL of vaccine remnant, in addition
to the patient's assigned dose. This limited vaccine waste. Patients
were premedicated with prednisone 40 mg the day prior and the
day of the second dose, and 10 mg of cetirizine. This regimen was
extrapolated from literature describing premedication for contrast
media reactions, to attenuate mast- cell mediated and T- cell medi-
ated reactions. Mast- cell mediated reactions were considered pos-
sible, given skin testing did not confirm IgE reactions. Both patients
received their doses successfully, with no objective reaction. Patient
1 described heat to her face with the final graded dose, but had no
visible flushing or hemodynamic changes.
As discussed by Cabanillas et al, allergy testing to PEG should
be considered when patients react to the Pfizer vaccine; if negative,
testing to PEGylated liposomes should be considered.4 As done by
Troelnikov and in our study, skin testing to vaccine remnants is also
suggested.4
© 2021 EA ACI and Jo hn Wiley and Sons A /S. Published by John Wil ey and Sons Ltd.
TAB LE 1 Desensitization regimen for vaccine administration
Solution
Volume
(equivalent vaccine
volume)
Time following
previous dose
Dilute vaccine, 1:10 0.1 mL (0.01 mL) 10 min
Dilute vaccine, 1:10 0.4 mL (0.04 mL) 10 min
Full concentration
vaccine
0.05 mL 15 min
Full concentration
vaccine
0.10 mL 15 min
Full concentration
vaccine
0.15 mL 15 min