Analysis of participant-reported adverse events following the first dose of inactivated SARS-Cov-2 vaccine (TURKOVAC™) through telephone survey in Türkiye

Figures & data

Figure 1. Questionnaire algorithm used by the call center during the telephone survey following the first dose TURKOVAC vaccine, Turkey, 10–17 January 2022. The ‘Other’ adverse events stated in the algorithm were open-ended. During the call, the ‘other’ adverse events reported by the participants were noted as open-ended text.

Table 1. Baseline characteristics of the participants by follow-up day.

	Day 3 (n = 6023)		Day 7 (n = 5345)
	(n)	(%)	(n)	(%)
Sex
Male	3585	59.5	3233	60.5
Female	2438	40.5	2112	39.5
Age group
19–39	1513	25.1	1310	24.5
40–55	2128	35.3	1909	35.7
56–64	1371	22.8	1243	23.3
65–75	878	14.6	768	14.4
76+	133	2.2	115	2.2
Mean ± SD	50 ± 14.4		50.1 ± 14.2
Med (min–max)	51 (19–91)		51 (19–89)
Vaccine dose^a
1	728	12.1	632	11.8
3	3444	57.2	3064	57.3
4	1700	28.2	1516	28.4
5	151	2.5	133	2.5

^aThe term ‘vaccine dose’ is used to define the number of doses of total COVID-19 vaccines including the TURKOVAC vaccine as the latest dose.

Table 2. Sex and age distribution of the participants by follow-up day.

	Day 3 (n = 6023)	Day 7 (n = 5345)
Male	50.7 ± 14.4	50.7 ± 14.3
	52 (19–91)	52 (19–89)
Female	49.0 ± 14.3	49.3 ± 14.0
	50 (19–86)	51 (19–86)
Total	50 ± 14.4	50.1 ± 14.2
	51 (19–91)	51 (19–89)

Figure 2. Distribution of participants by the number of doses of total COVID-19 vaccines (including the TURKOVAC vaccine as the latest dose) by follow-up days.

Table 3. Rates of adverse events reported by the participants by follow-up day.

Adverse event	Day 3 (n = 6023)		Day 7 (n = 5345)
	n	Adverse event rate%	n	Adverse event rate%
Any adverse event	2207	36.6	1201	22.5
Local
On the injection site	1789	29.7	698	13.1
Pain	1680	93.9	662	94.8
Induration	290	16.2	145	20.8
Swelling	213	11.9	105	15.0
Redness	49	2.7	42	6.0
Involvement of joint
Pain	351	20.9	200	30.2
Induration	61	21.0	58	40.0
Swelling	36	16.9	34	32.4
Redness	7	14.3	14	33.3
Systemic
Headache	479	7.9	426	8.0
Fatigue/Weakness	577	9.6	441	8.3
Other	285	4.7	121	2.3
Self-reported fever (≥38 °C)	67	1.1	76	1.4
Rise in blood pressure	63	1.0	74	1.4
Drop in blood pressure	45	0.7	57	1.1
Influence on daily living	247	4.1	233	4.4

Table 4. Comparative analysis of adverse events among participants who received TURKOVAC as their first COVID-19 vaccine compared to participants who received TURKOVAC as a booster dose.

	Covariates	Day 3			Day 7
		Adverse Event Rate %	RR (95% CI)	p	Adverse Event Rate %	RR (95% CI)	p
Any adverse event
Vaccine dose	TURKOVAC as the 1st dose	48.2	1.4 (1.3–1.5)	<0.001	29.4	1.4 (1.2–1.6)	<0.001
	TURKOVAC as a booster dose^a	35.1	1		21.5	1
Pain
Vaccine dose	TURKOVAC as the 1st dose	36.7	1.4 (1.2–1.5)	<0.001	16.1	1.4 (1.1–1.7)	0.002
	TURKOVAC as a booster dose^a	26.7	1		11.9	1
Redness
Vaccine dose	TURKOVAC as the 1st dose	1.6	2.4 (1.2–4.5)	0.008	1.1	1.5 (0.7–3.3)	0.333
	TURKOVAC as a booster dose^a	0.7	1		0.7	1
Swelling
Vaccine dose	TURKOVAC as the 1st dose	5.2	1.6 (1.1–2.2)	0.009	3.3	1.9 (1.2–3.0)	0.009
	TURKOVAC as a booster dose^a	3.3	1		1.8	1
Induration
Vaccine dose	TURKOVAC as the 1st dose	6.7	1.5 (1.1–2.0)	0.010	4.0	1.6 (1.1–2.4)	0.041
	TURKOVAC as a booster dose^a	4.6	1		2.5	1
Fatigue/Weakness
Vaccine dose	TURKOVAC as the 1st dose	13.7	1.5 (1.3–1.9)	<0.001	12.2	1.6 (1.3–2.0)	<0.001
	TURKOVAC as a booster dose^a	9.0	1		7.7	1
Headache
Vaccine dose	TURKOVAC as the 1st dose	11.4	1.5 (1.2–1.9)	<0.001	11.7	1.6 (1.2–2.0)	<0.001
	TURKOVAC as a booster dose^a	7.5	1		7.5	1
Self-reported fever (≥38 °C)
Vaccine dose	TURKOVAC as the 1st dose	1.6	1.6 (0.9–3.0)	0.141	2.2	1.7 (1.0–3.0)	0.073
	TURKOVAC as a booster dose^a	1.0	1		1.3	1
Drop in blood pressure
Vaccine dose	TURKOVAC as the 1st dose	1.5	2.4 (1.2–4.6)	0.011	1.7	1.8 (0.9–3.4)	0.079
	TURKOVAC as a booster dose^a	0.6	1		1.0	1
Rise in blood pressure
Vaccine dose	TURKOVAC as the 1st dose	1.1	1.1 (0.5–2.2)	0.881	0.8	0.5 (0.2–1.3)	0.174
	TURKOVAC as a booster dose^a	1.0	1		1.5	1
Impact on daily living
Vaccine dose	TURKOVAC as the 1st dose	7.1	1.9 (1.4–2.6)	<0.001	7.6	1.9 (1.4–2.6)	<0.001
	TURKOVAC as a booster dose^a	3.7	1		3.9	1

^aAs primary vaccination or first or second booster with other vaccines, and TURKOVAC as the last booster dose.

Statistically significant one is given as bold. 

Table 5. Adjusted odds for selected adverse events following the first dose of TURKOVAC vaccine.

	Covariates	Day 3		Day 7
		Adverse event rate %	ORADJ (95% CI)	Adverse event rate %	ORADJ (95% CI)
Any adverse event
Age	19–39	43.4	2.9 (1.9–4.5)	26.1	2.7 (1.5–4.9)
	40–55	38.7	2.5 (1.6–3.9)	23.8	2.5 (1.3–4.5)
	56–64	32.5	1.8 (1.2–2.8)	20.9	2.0 (1.1–3.6)
	65–75	28.8	1.5 (1.0–2.4)	17.1	1.5 (0.8–2.8)
	76+	20.3	1	11.3	1
Sex	Male	30.3	1	18.3	1
	Female	46.0	1.9 (1.7–2.1)	28.9	1.8 (1.6–2.0)
Vaccine dose	1	48.2	2.1 (1.4–3.2)	29.4	2.2 (1.2–3.9)
	3	36.2	1.4 (0.9–2.1)	22.0	1.6 (0.9–2.8)
	4	33.8	1.7 (1.2–2.6)	21.4	2.0 (1.2–3.5)
	5	21.9	1	11.3	1
Pain (on the injection site)
Age	19–39	34.0	2.7 (1.7–4.4)	14.8	2.2 (1.1–4.5)
	40–55	29.1	2.2. (1.4–3.7)	13.2	2.0 (.0–4.0)
	56–64	24.1	1.6 (1.0–2.6)	11.3	1.5 (0.7–3.0)
	65–75	22.1	1.4 (0.9–2.3)	8.6	1.0 (0.5–2.1)
	76+	16.5	1	7.8	1
Sex	Male	22.1	1	9.7	1
	Female	36.4	2.0 (1.8–2.3)	16.5	1.8 (1.5–2.1)
Vaccine dose	1	36.7	2.0 (1.2–3.2)	16.1	3.1 (1.2–7.7)
	3	27.5	1.4 (0.9–2.2)	11.8	2.3 (0.9–5.8)
	4	25.9	1.7 (1.1–2.7)	12.7	3.5 (1.4–8.6)
	5	16.6	1	3.8	1
Swelling (on the injection site)
Age	19–39	5.0	2.3 (0.7–7.9)	2.1	0.9 (0.2–3.3)
	40–55	3.2	1.5 (0.4–5.1)	2.3	1.1 (0.3–4.0)
	56–64	3.1	1.2 (0.4–4.2)	1.6	0.6 (1.2–2.0)
	65–75	2.7	1.1 (0.3–3.7)	1.4	0.4 (0.1–1.6)
	76+	2.3	1	2.6	1
Sex	Male	1.6	1	0.8	1
	Female	6.4	4.1 (3.0–5.7)	3.7	4.7 (3.0–7.3)
Vaccine dose	1	5.2	2.3 (0.5–10.1)	3.3	2.4 (0.3–18.9)
	3	3.2	1.7 (0.4–7.0)	1.5	1.0 (0.1–8.0)
	4	3.6	2.5 (0.6–10.5)	2.5	2.7 (0.4–20.2)
	5	1.3	1	0.8	1
Induration (on the injection site)
Age	19–39	5.8	7.3 (1.0–53.9)	2.8	1.1 (0.3–3.9)
	40–55	5.5	7.3 (1.0–53.7)	3.1	1.3 (0.4–4.5)
	56–64	3.9	4.8 (0.7–35.8)	1.9	0.7 (0.2–2.3)
	65–75	3.5	4.6 (0.6–33.8)	2.7	0.9 (0.3–3.2)
	76+	0.8	1	2.6	1
Sex	Male	2.7	1	1.4	1
	Female	7.9	3.1 (2.4–4.0)	4.7	3.5 (2.5–5.1)
Vaccine dose	1	6.7	2.2 (0.7–7.5)	4.0	1.8 (0.4–8.0)
	3	4.8	1.7 (0.5–5.5)	2.3	1.1 (0.3–4.5)
	4	4.2	1.9 (0.6–6.2)	3.0	1.7 (0.4–7.2)
	5	2.0	1	1.5	1
Fatigue/Weakness
Age	19–39	12.9	0.4 (0.2–0.9)	10.4	0.6 (0.3–1.4)
	40–55	9.0	0.6 (0.3–1.4)	8.2	0.7 (0.3–1.8)
	56–64	8.3	0.6 (0.3–1.5)	6.9	0.9 (0.4–2.1)
	65–75	8.1	0.6 (0.3–1.4)	7.4	0.8 (0.3–1.8)
	76+	4.5	1	5.2	1
Sex	Male	6.2	1	5.4	1
	Female	14.5	0.4 (0.3–0.5)	12.6	0.4 (0.3–0.5)
Vaccine dose	1	13.7	0.5 (0.2–1.1)	12.2	0.2 (0.1–0.8)
	3	9.6	0.7 (0.3–1.4)	7.9	0.3 (0.1–1.1)
	4	8.2	0.7 (0.3–1.5)	7.8	0.3 (0.1–1.0)
	5	5.3	1	2.3	1
Headache
Age	19–39	9.3	0.5 (0.2–1.3)	8.9	0.2 (0.1–1.0)
	40–55	8.3	0.5 (0.2–1.4)	8.6	0.2 (0.1–1.0)
	56–64	7.1	0.5 (0.2–1.5)	7.2	0.3 (0.1–1.1)
	65–75	6.7	0.5 (0.2–1.3)	6.9	0.3 (0.1–1.1)
	76+	3.0	1	1.7	1
Sex	Male	5.0	1	5.5	1
	Female	12.3	0.4 (0.3–0.5)	11.8	0.5 (0.4–0.5)
Vaccine dose	1	11.4	0.3 (0.1–0.8)	11.7	0.3 (0.1–0.9)
	3	8.2	0.4 (0.1–1.0)	7.8	0.5 (0.2–1.3)
	4	6.4	0.5 (0.2–1.3)	7.3	0.5 (0.2–1.2)
	5	2.6	1	3.0	1
Self-reported fever (≥38 °C)
Age	19–39	1.3	0.8 (0.3–2.0)	1.2	0.7 (0.3–1.7)
	40–55	1.0	0.7 (0.3–1.7)	1.8	1.1 (0.5–2.4)
	56–64	1.2	0.9 (0.4–2.2)	1.0	0.6 (0.3–1.4)
	65+	0.9	1	1.5	1
Sex	Male	0.5	1	0.8	1
	Female	2.0	3.8 (2.2–6.4)	2.4	3.2 (1.9–5.1)
Vaccine dose	1	1.6	1.1 (2.2–5.4)	2.2	2.3 (0.3–18.8)
	3	1.2	0.9 (0.2–3.7)	1.3	1.3 (0.2–10.3)
	4	0.7	0.4 (0.1–2.0)	1.4	1.5 (0.2–11.2)
	5	1.3	1	0.8	1
Impact on daily living
Age	19–39	6.4	1.4 (0.5–4.0)	6.3	1.7 (0.6–4.8)
	40–55	4.5	1.0 (0.4–2.9)	4.3	1.2 (0.4–3.4)
	56–64	2.2	0.5 (0.2–1.6)	3.0	0.7 (0.3–2.1)
	65–75	2.4	0.7 (0.2–2.1)	3.6	0.9 (0.3–2.6)
	76+	3.0	1	3.5	1
Sex	Male	2.3	1	2.6	1
	Female	6.8	3.1 (2.4–4.1)	7.1	2.9 (2.2–3.7)
Vaccine dose	1	7.1	2.0 (0.6–6.6)	7.6	–
	3	4.4	1.4 (0.4–4.6)	3.9	–
	4	2.5	1.1 (0.3–3.5)	4.4	–
	5	2.0	1	0.0	1

Data availability statement

Raw data were generated at SABIM. Derived data supporting the findings of this study are available on request from the corresponding author, A.K. The data are not publicly available as the information contained may compromise the privacy of research participants.