Vineeta Pandey, a journalist with Deccan Chronicle ran pillar to post in the month of May 2021 to report an 'adverse event' her son showed signs of after he received his COVID-19 vaccine. At that time, the government had not displayed or shared the method to report an 'adverse event following COVID-19 immunisation' or AEFI as it is known.
Pandey's 21-year-old son got vaccinated at EDMC PS Trilokpuri Site 1 in East Delhi on May 13. After returning home, he reported fever, numbness which continued for two days. On consulting a doctor friend, Pandey was asked to report this as an AEFI as her son's nails had turned blue. That is when her ordeal began.
"At that time, in the peak of COVID-19, these doctors came through but the government did not help enough. There was no email ID listed and the numbers that the Ministry shared were constantly unavailable," Pandey told BOOM.
Vaccination centres have some written material explaining adverse events and require a person to wait for thirty minutes after getting their shot in order to observe any untoward event. Along with this, they are expected to display or share contacts of nodal officers for people to reach out to them if any adverse event arises in the days following vaccination.
However, many Indians are unaware about the procedures or the difficulty that may arise while reporting one.
On being told that it would be better if she visited the nodal officer of her vaccination site, Pandey visited the site at 5 pm on May 14 after her son's health stabilised. "I visited the school at 5 pm and the doctor on duty told me to speak to the nodal officer. The nodal officer assured me that he would take note but had no role as such in AEFI reporting. I tagged every official from the Ministry, ICMR who I knew were active on Twitter. Even tagged SII chairman Adar Poonawalla but received no responses," Pandey added.
After four days of trying to get the AEFI noted, Pandey finally reached out to a senior Ministry official. "All thanks to his intervention, a state surveillance officer called me and told me that she will get me in touch with the official. Eventually, it was finally registered."
"I am aware about the reporting mechanisms. But what about those who have no means or knowledge about these issues?" Pandey added.
The government as well as both the manufacturers- Covaxin manufacturer- Bharat Biotech and Covishield manufacturer -Serum Institute of India have AEFI reporting and grievance redressal mechanisms in place.
But, there have been reports of SII unlinking adverse events to Covishield. Earlier, a Chennai resident who was a part of the Covishield clinical trials sued the company after alleging an adverse event. SII responded that the event was not linked to the vaccine and filed a 100-crore defamatory suit against the man.
It is also pertinent that people are aware of the difference between side effects that are a normal, regular reaction to vaccines and effects that could be severe and adverse. A mild fever, acidity, body ache, these symptoms are considered to be regular side effects, while allergies, thrombosis, breathlessness, sudden paralysis, and death fall under serious and severe adverse event.
Highlighting another such incident, Siddhartha Das, member of All India Drug Action Network (AIDAN) shared a tweet on July 17 alleging SII did not consider a death following vaccine as and AEFI or being linked to the vaccine. The tweet also contains the email conversation between the doctor's brother and SII. This doctor, who got vaccinated in January, died in March due to a blood clotting event. Her brother who was continuously in touch with authorities in Gurugram where the doctor was first admitted and in Nashik where she received the vaccine, found that her death was not registered as an AEFI.
Das told BOOM that the family reached out to the committee and they assisted them in filing a complaint with the AEFI. However, the AEFI assessment is currently stalled, as the family has not received any conclusive report from National AEFI committee, so far.
The National AEFI committee has so far reviewed only close to 190 cases from the months of January to March. There have also been complaints of emails bouncing back.
BOOM spoke to Dr. Mangala Gomare, executive health officer, Mumbai Municipal Corporation to understand the process of reporting AEFIs. "Besides the 30-minute post vaccine observation, the recipients are given instructions and explained to reach out to the nodal officer if they face any issues. We also share the numbers of the ward war rooms which help the callers connect with their sites or for further steps."
For hospitals that are not a part of the municipal corporation, the civic body still facilitates reporting. "If patients go to the hospitals, if their medical history indicates that what they are feeling is a post-vaccination effect, the staff there notes it down, and shares it with us, Dr. Gomare added.
BOOM is further simplifying the process of reporting an AEFI for the readers.
How To Report An AEFI
1. At vaccination site, ask for number of nodal officer.
2. If any adverse symptoms do arise, contact nodal officer of vaccination site and consult. If AEFI, ask them to note and report.
3. If nodal officer is not available, contact Ministry and vaccine manufacturer helplines.
Ministry contact- Helpline numbers 1075 and 011-23978046, and technical number 0120-4473222. Email ids are- support@cowin.gov.in, pvpi.compat@gmail.com, pvpi.ipc@gov.in
For issues related to Covaxin, people can reach out to pvg@bharatbiotech.com or 1800-1022245.
SII's grievance contacts are pharmacovigilance@seruminstitute.com and 18001200124.
4. Follow up to see if it has been registered.