A two-month-old infant boy died on Jan. 11, 2020, a day after receiving the “5-in-1” pentavalent (diphtheria, pertussis, tetanus, hepatitis B and Haemophilus influenzae type B) vaccine at a rural child care center in Hunshyal, India. The child was rushed to a nearby hospital after he fainted, but he died on the way.1
The child, who had been given the BCG (Bacillus Calmette–Guérin) for tuberculosis (TB) shortly after birth, had been running a fever when he arrived at the center to be vaccinated, vomited several times after the vaccination and his fever worsened, according to an uncle who said, “The baby was suffering from mild fever for the past six days. … The nurse at the center failed to conduct a pre-check before giving the vaccine.”1
The nurse who administered the vaccine reportedly gave the child’s mother Paracetamol (acetaminophen) tablets. Many pediatricians in the United States routinely recommend giving acetaminophen (sold under the brand name Tylenol) to children for post-vaccination fever.1 2 3
A local health official, however, denied that the baby had a fever at the time of vaccination. The official noted that the child’s low weight may have contributed to the complications. “The baby weighed 2.25 kg, well below the standard for a two-month-old. He should have weighed over 3 kg at the very least,” the official said.1
Following inquiries with local health staff, a district reproductive and child health officer confirmed that the child had been suffering from a fever for several days but that when he was brought in to be vaccinated, “he seemed fine.”1
The pentavalent vaccine was introduced into India’s routine vaccination schedule for children during 2014-2015. The vaccine, which comes in vials of 10 doses each, is scheduled to be given to children three separate times—at six weeks, 10 weeks and 14 weeks of age.4 5 Pentavalent vaccines in India are manufactured by four pharmaceutical companies, including Serum Institute (Pentavac PFS), Panacea Biotecs (Easyfive TT), Biological E (ComBE Five) and Shantha Biotechnics (Shan5).6
2 Paracetamol Tablet. WebMD.
3 Cáceres M. Doctors Prescribe Acetaminophen for Fever After Vaccination. Really? The Vaccine Reaction Sept. 15, 2017.
4 Gavi, the Vaccine Alliance. Pentavalent vaccine introductions represent historic milestone for immunisation in India.
5 Ministry of Health and Family Welfare. Pentavalent Vaccine. Government of India 2012.
6 TVR Staff. Baby Girl in India Dies Day After Getting the Pentavalent Vaccine. The Vaccine Reaction July 3, 2019.
7 TVR Staff. Infant Boy in India Falls Unconscious and Dies After Vaccination. The Vaccine Reaction July 27, 2019.
8 TVR Staff. Infant Girl in India Dies Day After Receiving Oral Polio and Pentavalent Vaccines. The Vaccine Reaction Sept. 11, 2019.