Medical Editor: John P. Cunha, DO, FACOEP
Typhim (typhoid vi polysaccharide vaccine) is an immunization used to help prevent typhoid fever in adults and children who are at least 2 years old. Typhoid is a serious disease caused by Salmonella typhi bacteria and can be fatal if left untreated. Typhim vaccine is recommended for people who are traveling to areas where the infection is common (e.g., Africa, Asia, Central/South America), those who are in close contact to someone with persistent typhoid infection, and those who work with the bacteria in a laboratory. Common side effects of Typhim vaccine include:
- injection site reactions (pain, tenderness, redness, swelling, or a hard lump),
- low fever,
- stomach pain, or
Tell your doctor if you have serious side effects of Typhim vaccine including:
- swollen glands,
- rash or itching,
- body aches,
- general ill feeling, or
- feeling like you might pass out.
The immunizing dose of Typhim for adults and children is a single injection of 0.5 mL. Typhim may interact with blood thinners. Other drugs may affect this vaccine. Tell your doctor all medications you use, and all other vaccines you have recently received. During pregnancy, Typhim should be used only when prescribed. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.
Our Typhim (typhoid vi polysaccharide vaccine) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
You should not receive a booster vaccine if you had a life-threatening allergic reaction after the first shot.
Keep track of any and all side effects you have after receiving this vaccine. When you receive a booster dose, you will need to tell the doctor if the previous shots caused any side effects.
Becoming infected with typhoid is much more dangerous to your health than receiving the vaccine to protect against it. Like any medicine, this vaccine can cause side effects, but the risk of serious side effects is extremely low.
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have any of these serious side effects:
- fever, swollen glands, rash or itching, body aches;
- tremors, general ill feeling; or
- feeling like you might pass out.
Less serious side effects include:
- pain, tenderness, redness, swelling, or a hard lump where the shot was given;
- low fever;
- nausea, diarrhea, stomach pain; or
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report vaccine side effects to the US Department of Health and Human Services at 1-800-822-7967.
Read the entire detailed patient monograph for Typhim (Typhoid Vi Polysaccharide Vaccine)
Adverse event information is derived from clinical trials and worldwide post-marketing experience.
Data From Clinical Trials
Because clinical trials are conducted under widely varying conditions, adverse reactions rates observed in the clinical trials of a vaccine cannot be directly compared to rates in the clinical trials of another vaccine and may not reflect the rates observed in practice. The adverse reaction information from clinical trials does, however, provide a basis for identifying the adverse events that appear to be related to vaccine use and for approximating rates.
Safety of Typhim Vi vaccine, the US licensed liquid formulation, has been assessed in clinical trials in more than 4,000 subjects both in countries of high and low endemicity. In addition, the safety of the lyophilized formulation has been assessed in more than 6,000 individuals. The adverse reactions were predominately minor and transient local reactions. Local reactions such as injection site pain, erythema, and induration almost always resolved within 48 hours of vaccination. Elevated oral temperature, above 38.C (100.4.F), was observed in approximately 1% of vaccinees in all studies. No serious or life-threatening systemic events were reported in these clinical trials.10,11
Adverse reactions from two trials evaluating Typhim Vi vaccine lots in the US (18- to 40-year-old adults) are summarized in Table 3. No severe or unusual side effects were observed. Most subjects reported pain and/or tenderness (pain upon direct pressure). Local adverse experiences were generally limited to the first 48 hours.10,11
Table 3 10,11: PERCENTAGE OF 18- TO
40-YEAR-OLD US ADULTS PRESENTING WITH LOCAL OR SYSTEMIC REACTIONS WITHIN 48
HOURS AFTER THE FIRST IMMUNIZATION WITH TYPHIM Vi VACCINE
|REACTION||Trial 1 Placebo
N = 54
|Trial 1 Typhim Vi vaccine
N = 54 (1 Lot)
|Trial 2 Typhim Vi vaccine
N = 98 (2 Lots combined)
|Tenderness||7 (13.0%)||53 (98.0%)||95 (96.9%)|
|Pain||4 (7.4%)||22 (40.7%)||26 (26.5%)|
|Induration||0||8 (14.8%)||5 (5.1%)|
|Erythema||0||2 (3.7%)||5 (5.1%)|
|Malaise||8 (14.8%)||13 (24.0%)||4 (4.1%)|
|Headache||7 (13.0%)||11 (20.4%)||16 (16.3%)|
|Myalgia||0||4 (7.4%)||3 (3.1%)|
|Nausea||2 (3.7%)||1 (1.9%)||8 (8.2%)|
|Diarrhea||2 (3.7%)||0||3 (3.1%)|
|Feverish (subjective)||0||6 (11.1%)||3 (3.1%)|
|Fever ≥ 100°F||0||1 (1.9%)||0|
No studies were conducted in US children. Adverse reactions from a trial in Indonesia in children one to twelve years of age are summarized in Table 4.10,11 No severe or unusual side effects were observed.
Table 4 10,11: PERCENTAGE OF INDONESIAN
CHILDREN ONE TO TWELVE YEARS OF AGE PRESENTING WITH LOCAL OR SYSTEMIC REACTIONS
WITHIN 48 HOURS AFTER THE FIRST IMMUNIZATION WITH TYPHIM Vi VACCINE
|REACTIONS||N = 175|
|Impaired Limb Use||0|
|Decreased Activity||3 (1.7%)|
|* Subjective feeling of fever.|
In the US Reimmunization Study, subjects who had received Typhim Vi vaccine 27 or 34 months earlier, and subjects who had never previously received a typhoid vaccination, were randomized to placebo or Typhim Vi vaccine, in a double-blind study. Safety data from the US Reimmunization Study are presented in Table 5.10,11,13 In this study 5/30 (17%) primary immunization subjects and 10/45 (22%) reimmunization subjects had a local reaction. No severe or unusual side effects were observed. Most subjects reported pain and/or tenderness (pain upon direct pressure). Local adverse experiences were generally limited to the first 48 hours.10,11,13
Table 510,11,13: US REIMMUNIZATION STUDY,
SUBJECTS PRESENTING WITH LOCAL AND SYSTEMIC REACTIONS WITHIN 48 HOURS AFTER IMMUNIZATION
WITH TYPHIM Vi VACCINE
(N = 32)
(N = 30)
(N = 45*)
|Tenderness||2 (6%)||28 (93%)||44 (98%)|
|Pain||1 (3%)||13 (43%)||25 (56%)|
|Induration||0||5 (17%)||8 (18%)|
|Erythema||0||1 (3%)||5 (11%)|
|Malaise||1 (3%)||11 (37%)||11 (24%)|
|Headache||5 (16%)||8 (27%)||5 (11%)|
|Myalgia||0||2 (7%)||1 (2%)|
|Nausea||0||1 (3%)||1 (2%)|
|Feverish (subjective)||0||3 (10%)||2 (4%)|
|Fever ≥ 100°F||1 (3%)||0||1 (2%)|
|* At 27 or 34 months following a previous dose given in different studies.|
Solicited Injection Site and Systemic Reactions When Given With Menactra Vaccine
The majority (70%-77%) of solicited injection site reactions at the Typhim Vi and at the Menactra injection sites were reported as Grade 1 and resolved within 3 days post-vaccination. The most common systemic reactions were headache (41% when Menactra and Typhim Vi were given concomitantly; 42% when Typhim Vi was given with Placebo, and 33% when Menactra vaccine was given alone one month after Typhim Vi vaccination) and fatigue (38% when Menactra vaccine and Typhim Vi were given concomitantly; 35% when Typhim Vi was given with Placebo, and 27% when Menactra vaccine was given alone one month after Typhim Vi vaccination). Fever ≥ 40.0.C and seizures were not reported.
Data From Worldwide Post-Marketing Experience
In addition to reports in clinical trials, worldwide voluntary adverse events reports received since market introduction of Typhim Vi vaccine are listed below. This list includes serious events and/or events which were included based on severity, frequency of reporting or a plausible causal connection to Typhim Vi vaccine. Because these events were reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or establish a causal relationship to vaccination.
Nausea, vomiting, diarrhea, abdominal pain
General Disorders And Administration Site Condition
Immune System Disorders
Musculoskeletal And Connective Tissue Disorders
Nervous System Disorders
Respiratory System Disorders
Additional Adverse Events
Post-marketing reports of glomerulonephritis, neutropenia, bilateral retinitis, and polyarthritis have been reported in patients who had also received other vaccines; however, a causal relationship has not been established.
Reporting Of Adverse Events
Reporting by parents and patients of all adverse events occurring after vaccine administration should be encouraged. Adverse events following immunization with vaccine should be reported by the health-care provider to the US Department of Health and Human Services (DHHS) Vaccine Adverse Event Reporting System (VAERS). Reporting forms and information about reporting requirements or completion of the form can be obtained from VAERS through a tollfree number 1-800-822-7967 or visit the VAERS website at http//www.vaers.org.17
Health-care providers also should report these events to the Pharmocovigilance Department, Sanofi Pasteur Inc., Discovery Drive, Swiftwater, PA 18370, or call 1-800-8222463.
Read the entire FDA prescribing information for Typhim (Typhoid Vi Polysaccharide Vaccine)
© Typhim Patient Information is supplied by Cerner Multum, Inc. and Typhim Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.