Patient with blood clot admitted on March 6 – OUS only notified five days later – VG

VG can report today that the first patient with the combination of low platelets, blood clots and bleeding was admitted to the Oslo Rikshospitalet University Hospital on March 6.

Already at the time of admission, it was discussed whether the course of the disease could be related to the fact that the patient had recently taken the AstraZeneca vaccine.

However, the Oslo University Hospital (OUS) waited five days to notify the Norwegian health authorities of the possible connection.

If a possible serious side effect of a vaccine is suspected, health personnel should report it “as soon as possible,” according to the website of the National Institute of Public Health.

According to the legislation on notification of side effects of vaccines, “The notification of side effect or suspected side effect is reported as soon as it is made known to health personnel.”

The notification must be sent to the Norwegian Medicines Agency via the melde.no service.

– In general, we can say that doctors should report side effects if they suspect a connection, says the senior advisor to the Norwegian Medicines Agency, Pernille Harg.

For common drug side effects, healthcare professionals have no deadline to report. In the regulations related to vaccination, it is specified that the notification must be sent as soon as possible in case of suspicion.

Discuss the connection to the vaccine.

OUS confirms that upon admission it was discussed whether the course of the disease was related to the vaccine. The patient was transferred from Akershus University Hospital on Saturday, March 6.

VG is informed that there is a dialogue between the hospitals about the same day notification.

According to Akershus University Hospital, the hospital had “A clear understanding that OUS should consider reporting a possible connection to the covid vaccine to the Norwegian Medicines Agency.”

Ahus only found out a few days later that this had not been done, the hospital writes.

When asked why OUS waited five days to notify, the hospital responds that the reason was that the connection between the vaccine and the course of the disease was only one. possible indication.

Doctors worked from a broad diagnostic approach from the beginning, OUS writes in an email.

OUS explains that in the days after March 6, some of the alternative explanations for the patient’s pathological state disappeared and the suspicion of side effects of the vaccine was strengthened.

“The issue of notification to the Norwegian Medicines Agency (LMV) will be raised on both March 9 and 11”, writes the hospital in an email.

The notice was not sent until Thursday, March 11.

“If this indicates a late notification to the LMV, others will have to decide. We remind them that throughout this period we had the main focus on providing the patient with the best medical treatment based on an unresolved condition, and that this was more than demanding for all the health professionals involved. ” write OUS in an email.

I did not know about the Norwegian patient.

Norwegian health authorities stopped vaccination with AstraZeneca on March 11 following reports from Denmark of a death that could possibly be related to the vaccine.

One woman had a severe blood clot shortly after vaccination and died as a result.

At 2:00 pm on the same day, the Norwegian health authorities held a press conference in Oslo.

The Norwegian Institute of Public Health decided to discontinue vaccination with the AstraZeneca vaccine as a so-called “precautionary principle”.

At the press conference, Geir Bukholm, director of infection control at FHI, stated that only in reported a blood clot associated with the AstraZeneca vaccine and that this case was not serious.

He explained that based on Norwegian data, there was really no basis to stop vaccination with AstraZeneca in Norway:

– The reason we are doing it now is because it has created uncertainty and to show that we take this seriously, Bukholm said on March 11.

Bukholm was unaware at the time that there was a patient at Oslo University Hospital with a similar illness.

Neither FHI nor the Norwegian Medicines Agency had been notified of this when they attended the press conference on March 11.

I got the notice four hours later

According to the Norwegian Medicines Agency and the NIPH, the first report of possible serious side effects from the vaccine comes from the Oslo University Hospital at 5:16 p.m. today.

– We made our decision based on various evaluations and reports from other countries. It is difficult to know how this case would affect our basis for decision. It depends, among other things, on how this case would have been described at the relevant time, infection control director Geir Bukholm says today.

– Would FHI have had a different basis for evaluating the information from Denmark, had it also known of similar cases in Norway?

– All the additional information on these cases would have strengthened our decision base, says Bukholm.

According to the Oslo University Hospital, the notification was sent to the Norwegian Medicines Agency on March 11 at 1:57 p.m., three minutes before the press conference.

The notification contained a brief description of the patient’s case and a possible connection to the vaccine.

“Before this, a telephone attempt was also made. The doctor will receive a response to his notification by e-mail the next day, that is, on March 12 at 11:22, that the Norwegian Medicines Agency cannot receive reports of side effects from health personnel by e-mail. “

– Several cases at the same time helped to open the eyes.

Chief physician Sigurd Hortemo of the Norwegian Medicines Agency confirms that he did not know of any Norwegian cases when the first reports came from Denmark, but says that one case of illness in Norway would not have been enough to stop vaccination earlier:

– If we had been notified of such a disease, without having had the background information on cases in Denmark and other countries, we probably would have done nothing more than report it in our national database and at the same time register it in the database European, says Hortemo.

– The fact that Rikshospitalet received several cases at the same time, helped to open our eyes, we must be able to say. The fact that several similar cases were received at the same time, as well as reports of similar cases in Austria and Denmark, contributed to a clearer pattern.