Table 1.
Summary of Symptoms After Dose 1 and Outcomes of Second Doses
| Symptom | Dose 1 |
Dose 2 |
|||||
|---|---|---|---|---|---|---|---|
| N (%) | Pfizer (N) | Moderna (N) | Received second dose (N), if symptoms knowna | Same symptoms recurred, if known (N) | Pfizer (N) | Moderna (N) | |
| Hives or angioedema | 18 (26.1%) | 16 | 2 | 13b | 5 (38%) | 4 | 1 |
| New onset hives | 9 | 9 | 0 | 5 | 1 (20%) | 1 | 0 |
| New onset angioedema | 4 | 4 | 0 | 4 | 1 (25%) | 1 | 0 |
| Flaring long-term hives | 5 | 3 | 2 | 4 | 3 (75%) | 2 | 1 |
| Anaphylaxisc | 2 (2.9%) | 1 | 1 | 2 | Both desensitized,d no adverse events | ||
| Delayed onset rash | 5 (7.2%) | 3 | 2 | 3 | 0 (0%) | ||
| Large local reaction | 2 | 1 | 1 | 0 | |||
| Lip dermatitis | 1 | 1 | 0 | 1 | 0 (0%) | ||
| Viral exanthem | 2 | 1 | 1 | 2 | 0 (0%) | ||
| Subjective itching, warmth, SOB, palpitations, and/or throat tightness | 22 (31.9%) | 15 | 7 | 18 (6 supervised, 2 by graded challenge) |
8 (44%) | 7 | 1 |
| Dizziness, numbness, tingling, tinnitus, and/or vision changes |
11 (16.6%) | 8 | 3 | 7 | 1 (17%) | 0 | 1 |
| Loss of smell/taste | 1 (1.4%) | 1 | 0 | 0 | |||
| GI symptoms | 1 (1.4%) | 0 | 1 | 1 | 0 (0%) | ||
| Expected symptoms including headache, fever, body aches |
6 (8.7%) | 5 | 1 | 4 | 3 (75%) | 2 | 1 |
| Total | 66 | 49 (74%) | 17 (26%) | 48 (72.7%)e | 17 (36%) | 13 (76%) | 4 (24%) |
Abbreviations: GI, gastrointestinal; SOB, shortness of breath.
a
Patients were contacted after their second dose to assess the recurrence of symptoms. Those that responded are summarized here. None developed a different type of symptom. None had anaphylaxis.
b
Four pretreated with antihistamines.
c
Both patients developed hives, flushing, shortness of breath, and feeling of impending doom within 30 minutes.
d
A 6-step graded-dose protocol with Pfizer vaccine (0.003 mL, 0.009 mL, 0.018 mL, 0.04 mL, 0.08 mL, 0.15 mL; final volume 0.3 mL).
e
Five additional patients received the vaccine but could not be reached; recurrence of symptoms is unknown.