TABLE 1. Symptoms and health impacts reported to V-safe for persons aged ≥60 years who received a respiratory syncytial virus vaccine, by manufacturer — United States, May 3, 2023–April 14, 2024.
| Event | % Reporting symptoms or health impact after vaccination* (no.) |
|||
|---|---|---|---|---|
| GSK | Pfizer | Do not know/Cannot recall | Total | |
|
No. of participants
|
6,402 |
3,882 |
5,936 |
16,220
|
|
Symptoms reported as related to vaccination
|
48.6 (3,113) |
27.3 (1,058) |
36.3 (2,157) |
39.0 (6,328)
|
|
Injection site symptoms
|
43.9 (2,808) |
20.3 (787) |
31.1 (1,846) |
33.5 (5,441)
|
| Pain |
41.3 (2,641) |
17.7 (688) |
28.6 (1,697) |
31.0 (5,026)
|
| Swelling |
11.5 (737) |
5.6 (217) |
8.4 (497) |
8.9 (1,451)
|
| Redness |
10.5 (671) |
5.0 (195) |
8.1 (478) |
8.3 (1,344)
|
| Itching |
6.4 (412) |
4.2 (162) |
5.6 (330) |
5.6 (904)
|
| Underarm swelling or tenderness |
2.6 (165) |
1.8 (69) |
1.4 (84) |
2.0 (318)
|
| Rash |
1.6 (101) |
1.0 (38) |
1.4 (86) |
1.4 (225)
|
|
Systemic symptoms
|
36.6 (2,344) |
21.6 (839) |
27.9 (1,656) |
29.8 (4,839)
|
| Fatigue or tiredness |
25.6 (1,640) |
13.3 (515) |
19.7 (1,172) |
20.5 (3,327)
|
| Muscle or body aches |
22.0 (1,407) |
12.5 (484) |
16.0 (952) |
17.5 (2,843)
|
| Headache |
19.2 (1,227) |
10.6 (413) |
13.8 (820) |
15.2 (2,460)
|
| Fever† |
13.1 (836) |
7.5 (293) |
10.7 (636) |
10.9 (1,765)
|
| Chills |
12.1 (772) |
5.8 (226) |
8.3 (493) |
9.2 (1,491)
|
| Joint pain |
11.8 (756) |
6.6 (255) |
8.0 (477) |
9.2 (1,488)
|
| Nausea |
5.0 (317) |
3.2 (123) |
4.2 (249) |
4.2 (689)
|
| Diarrhea |
3.1 (201) |
2.1 (80) |
2.9 (172) |
2.8 (453)
|
| Rash |
0.5 (32) |
0.5 (20) |
0.5 (30) |
0.5 (82)
|
| Vomiting |
0.4 (25) |
0.3 (13) |
0.6 (36) |
0.5 (74)
|
| Other§ |
3.9 (248) |
2.5 (98) |
2.8 (168) |
3.2 (514)
|
|
Health impact
|
10.2 (654) |
6.2 (239) |
8.8 (524) |
8.7 (1,417)
|
| Unable to complete normal daily activities |
9.1 (580) |
5.3 (205) |
8.1 (479) |
7.8 (1,264)
|
| Unable to work or attend school |
1.9 (119) |
1.3 (51) |
1.7 (99) |
1.7 (269)
|
| Care from health care professional¶ |
0.5 (29) |
0.5 (19) |
0.3 (20) |
0.4 (68)
|
| Office visit or urgent care |
0.2 (14) |
0.3 (12) |
0.2 (11) |
0.2 (37)
|
| Telehealth |
0.2 (10) |
0.1 (2) |
0.1 (3) |
0.1 (15)
|
| Emergency department |
0.03 (2) |
0.1 (3) |
0.1 (7) |
0.1 (12)
|
| Hospitalization |
0.02 (1) |
0.03 (1) |
0.03 (2) |
0.02 (4)
|
| Other | 0.1 (8) | 0.1 (2) | 0 (—) | 0.1 (10) |
* Percentage of participants who reported a symptom or health impact at least once during days 0–7 postvaccination.
† Fever is a self-reported symptom and might not reflect the clinical definition of fever.
§ Among those who reported “Other” symptoms, 409 selected additional symptoms from a dropdown menu; most commonly selected were sore throat (54), dizziness (38), runny nose (38), cough (27), dizziness upon standing (17), and congestion (16).
¶ Participants can select from more than one type of care received from a health professional, including doctor appointment or urgent care clinic visit, telehealth, virtual health, or email health consultation, emergency department or emergency department visit, hospitalization, and other.