As vaccine mandates continue to be implemented throughout the country, precautions should be taken to ensure the information needed in the event of a vaccine injury, is carefully documented. Parents have many important records to keep for their children; school schedules, dietary restrictions, and doctor’s contact information to name a few. But there is no more commonly requested health information than immunization records. Though health practitioners will keep these records, there is additional information that parents may need to access. Tracking vaccine information, therefore, is a must.
Vaccine Record Keeping
It is suggested to keep a vaccine folder or notebook where you can document the vaccines your child received, the date of the vaccination, the exact location on the limb where the injection was given, and the lot number of the vaccine. Should an adverse reaction occur, you should immediately inform your doctor, so they can document the reaction in your child’s health record.
Additionally, either you or the doctor should report the adverse event to the Vaccine Adverse Event Reporting System (VAERS), a post-licensure, passive surveillance system monitored by the Centers for Disease Control (CDC). The VAERS system allows the CDC to track adverse events associated with specific vaccines.
Most vaccines are named with acronyms often representing multiple viruses in a single injection. These combination vaccines can make it confusing for parents to know just what diseases each shot is meant to protect against as well as what ingredients are in each shot. The Vaccine Information Statement (VIS) provided by your health care provider at the time of the vaccination, contains important information that specifies the diseases you are vaccinating against as well as possible adverse reactions associated with the shot. While vaccines are intended to protect against some harmful communicable diseases, not all are safe for all people.
The VIS will indicate who should not get vaccinated with certain vaccines because of age, health conditions, or other factors. It is a good idea to ask your healthcare practitioner to supply those sheets in advance of your visit, so you can educate yourself about the risks and benefits of each immunization. You can also ask to see the vaccine insert, which comes in the box with the vaccine vials, which will have much more extensive information on every detail about the vaccine, including the contraindications.
Batch vs. Lot vs. Unit of Sale
Vaccines are manufactured in batches called lots; once bottled, each lot is then labeled with a lot number. A vaccine lot number can provide the complete history of the manufacturing, processing, packing, holding, and distribution of a batch or lot. Vaccines are chemically treated biologics. As the FDA points out: “Most drugs consist of pure chemical substances and their structures are known. Most biologics, however, are complex mixtures that are not easily identified or characterized.”
Some manufacturers use a lot number on the packaging, called a Unit of Sale. A different number may be used on the vial or syringe itself, called a Unit of Use. This can cause some confusion, not only for record keeping but for tracking. The CDC uses lot numbers to track batches or lots that may have safety concerns and warrant recall. Sometimes manufacturer’s quality testing detects some irregularities in vaccine vials which have led to recall. Having the lot number allows that vaccine to be tracked back to the recipient. These inconsistencies in labeling can impact patient safety and inventory. In June 2017, The CDC released guidelines to ensure providers are aware of these inconsistencies to enable them to effectively recall if necessary.
While it is the duty of the healthcare provider to track and monitor immunization records, the act of independent record keeping can serve as invaluable should an adverse reaction occur. One way to document the vaccines received is to take a picture of the lot numbers on the vial / syringe AND the box the vial / syringe came in which includes the manufacturer’s name and batch or lot number. Having record of both will ensure the appropriate information is documented if a vaccine injury should occur.
Tracking Adverse Events
Systems for tracking adverse events were developed after the creation of the National Childhood Vaccine Injury Act (NVCIA) of 1986. The NVCIA was designed to put safeguards in place for mass vaccination programs and to ensure that those who are vaccine injured are compensated through the National Vaccine Injury Compensation Program (NVICP). The Vaccine Safety Datalink (VSD) is a collaboration between the CDC and 8 health care organizations which collects data through electronic health records. The VSD started collecting data in 1990 and includes date of administration of all vaccines given in one day, types of vaccines, medical illnesses, and any urgent care or hospital visits. With this data, adverse events reported through VAERS is studied.
The FDA’s post-licensure surveillance system known as PRISM (Post-Licensure Rapid Immunization Safety Monitoring), is the largest vaccine safety surveillance system in the United States used to actively monitor and analyze data from over 190 million people. PRISM links data from health plans with data from state and city immunization registries to identify and analyze rare health outcomes using diagnostic codes from consumer health plans. Having correct lot numbers is imperative for linking events associated with specific lots.
Before passive and active post-licensure surveillance systems were created, the general public relied on the results of pre-licensure clinical trials which were effective at identifying common adverse events that occur within the study period, however, they did not necessarily capture adverse events associated with delayed onset. Clinical trials only include healthy individuals therefore, vulnerable populations are generally not studied.
One of VAERS earliest successes in tracking adverse events associated with a particular vaccine was in 1998 with RotaShield, a rotavirus vaccine. This vaccine was associated with intussusception, a type of bowel obstruction in infants which was detected through VAERS. After investigation, the CDC suspended its recommendation of RotaShield and it was withdrawn from the market.
During the 2010-2011 flu season, VAERS picked up another signal of disproportional reporting for febrile seizures in young children following inactivated influenza vaccine. While a clinical review of the VAERS reports indicated the cases were typical of uncomplicated febrile seizures, a similar finding was detected through the VSD showing this increased risk of febrile seizures. The public was then notified of the risks vs benefits of vaccinating against influenza.
In 1979, The Tennessee Department of Health reported 4 sudden and unexplained infant deaths who all died within 24 hours of receiving a DPT vaccination. All of the babies had received the DPT from the same lot, Lot A. However, an investigation of Lot A which contained over 361,000 doses, found the vaccine to be acceptable with regard to potency and toxicity, therefore, it was determined there was no evidence to support such a causal association between the DPT vaccine and the Tennessee SIDS deaths.
Calculate Ingredient Totals
There are tools available to assist a parent in tracking vaccine lot information. If you are seeking more complete information about the vaccine you can do a lot search by registering for a VaxCalc™ account. Information on its ingredients as well as any associated adverse events associated with your lot number can be found. Some parents find it reassuring to get the lot number in advance of their appointment enabling them look up the lot number before their child is vaccinated.
Likewise, if an adverse event is ever reported to the US Government via the Vaccine Adverse Event Reporting System (VAERS), and is associated with the lot number, you will receive an alert email. As a parent, knowing the lot number is critical should an adverse reaction occur. In addition to the safeguards developed within the National Childhood Vaccine Injury Act comes the acknowledgement that vaccines do carry serious risks, while also preventing some diseases. To date, the Vaccine Injury Compensation Program (NVICP) has awarded nearly $4 billion to vaccine injured individuals and their families.
Vaccine hesitancy has become more prevalent, perhaps because they are generally given to healthy people as opposed to medications which are typically given to the ill, and, it is difficult to imagine unnecessary harm being caused to otherwise healthy individuals. If a serious adverse reaction occurs, the documented information, including the vaccine lot numbers, will be helpful for reporting and might be used as evidence if compensation is sought through the NVICP.