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Tresivac

Tresivac Adverse Reactions

Manufacturer:

Serum Institute of India

Distributor:

Genpharm
Full Prescribing Info
Adverse Reactions
The type and rate of severe adverse reactions do not differ significantly from the measles, mumps and rubella vaccine reactions described separately.
The measles vaccine may cause within 24 hours of vaccination mild pain and tenderness at the injection site. In most cases, they spontaneously resolve within two to three days without further medical attention. A mild fever can occur in 5-15% of vaccinees 7 to 12 days after vaccination and last for 1-2 days. Rash occurs in approximately 2% of recipients, usually starting 7-10 days after vaccination and lasting 2 days. The mild side effects occur less frequently after the second dose of a measles-containing vaccine and tend to occur only in person not protected by the first dose. Encephalitis has been reported following measles vaccination at a frequency of approximately one case per million doses administered although a causal link is not proven.
The mumps component may result in parotitis and low grade fever. Febrile seizures and orchitis may also occur. However, moderate fever occurs rarely and aseptic meningitis has been reported very rarely. Vaccine-associated meningitis resolves spontaneously in less than 1 week without any sequelae. The onset of aseptic meningitis is delayed, which may limit the ability to detect these cases by passive surveillance. Vaccine associated aseptic meningitis is observed between 15-35 days post immunization.
The rubella component may commonly result in joint symptoms manifested as arthralgias (25%) and arthritis (10%) among adolescent and adult females that usually last from a few days to 2 weeks. However, such adverse reactions are very rare in children and in men receiving MMR vaccine (0%-3%). Symptoms typically begin 1-3 weeks after vaccination and last 1 day to 2 weeks. These transient reactions seem to occur in non-immunes only, for whom the vaccine is important. Low-grade fever and rash, lymphadenopathy, myalgia and paraesthesiae are commonly reported. Thrombocytopenia is rare and has been reported in less than 1 case per 30 000 doses administered. Anaphylactic reactions are also rare. In susceptible individuals the vaccine may very rarely cause allergic reactions like urticaria, pruritis and allergic rash within 24 hours of vaccination. Clinical experience has exceptionally recorded isolated reactions involving the CNS. These more serious reactions have however, not been directly linked to vaccination.
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