Haku

FINE-044758

Tulosta

Asianumero: FINE-044758 (2022)

Vakuutuslaji: Lääkevahinkovakuutus

Ratkaisu annettu: 31.03.2022

A probable causal connection between the Comirnaty coronavirus vaccine given to the customer and the pulmonary embolism that he sustained in both lungs after he had received the vaccine. Should the pulmonary embolism have been compensated as a pharmaceutical injury caused by the Comirnaty vaccine?

Information on the events

A (b. 1986) received the Comirnaty coronavirus vaccine on 21 May 2021. On 30 May 2021, he attended the emergency department because of general weakness and fatigue. The FIDD value was found to be elevated, indicating a blood clot. On 31 May 2021, A was given a CT scan, which revealed a pulmonary embolism (blood clot of the lung) in both lungs. In his pharmaceutical injury notification dated 6 September 2021, A submitted that the pulmonary embolism was caused by the Comirnaty vaccine and made a claim for compensation under the pharmaceutical insurance.

The insurance company stated in its compensation decision on 25 October 2021 that, in order for the symptoms to be compensable as a pharmaceutical injury, there has to be a probable causal connection between the use of a medicine and the observed symptoms. The company said that a connection is known to exist between adenovirus vector vaccines and some types of blood clots. On the other hand, mRNA vaccines, such as the Comirnaty vaccine received by A, are not known to have the capacity to cause blood clots. The company considers that the probability of a causal connection between the administration of the vaccine and the pulmonary embolism was not sufficient to make it a compensable pharmaceutical injury. A’s claim for compensation was thus rejected with regard to the pulmonary embolism. However, the company observed that according to A’s patient records, the vaccine had caused a fever reaction that lasted a few days. The company instructed A to fill out a claim form concerning this reaction.

In its compensation decision on 24 November 2021, the insurance company considered that the fever reaction had not caused A any damage that would be compensable from the pharmaceutical insurance, such as treatment costs or other costs or loss of income. The costs and loss of income included in A’s claim were related to the pulmonary embolism, which had not been caused by the vaccine he received.

The customer’s complaint

A states his dissatisfaction with the insurance company’s compensation decision with regard to the pulmonary embolism. According to A, he was told by a doctor treating him that the pulmonary embolism was due to the Comirnaty vaccine. After the embolism, A has had to use Inhixa and Rosuvastatin medication. Inhixa has now been replaced with Xarelto. A cannot work due to his medication, because any accident might lead to severe bleeding. He has suffered a loss of income, which still continues.

Reply by the insurance company

The insurance company repeats its earlier stance. The Comirnaty vaccine is not known to increase the general risk of blood clots. A causal connection between the vaccine and pulmonary embolism is unlikely.

Medical reports

The Insurance Complaints Board has at its disposal medical reports concerning A over the period of 30 May to 25 November 2021.

According to the emergency department’s patient record dated 30 May 2021, A attended the emergency department because of general weakness and fatigue. A had received the Comirnaty vaccine, and since then he had felt tired and had pain in both legs. He had also felt some shortness of breath. At the consultation, A described pain in his calves, especially at the right side, and some general muscle aches. The FIDD laboratory value was elevated, indicating a blood clot. A was given a Klexane injection, and an ultrasound examination of the legs and a chest X-ray were programmed for the following morning.

According to the patient record from 31 May 2021, A said that he received the Comirnaty coronavirus vaccine on 21 May 2021. The following day, A developed a fever (38.5 degrees at most) that lasted for four days. After receiving the vaccine, he also started to experience flash-like headache symptoms and his eyes became sensitive to light. Over the last few days, he had also felt feverish in the evenings. In addition, he had experienced shortness of breath during exertion, as well as dizziness. On 26 May 2021, A started to feel pain in both calves, which had worsened over the last few days. A was able to walk 10 metres, after which the pain forced him to stop. In general, A does not get much exercise on weekdays, but he takes walks at weekends. He had not been particularly inactive recently compared to earlier times. A had not undergone any surgical operations. He was not aware of any predisposition for blood clots in his family. The chest X-ray and leg ultrasound results did not indicate a blood clot. A was given a contrast CT of the lungs, which revealed a pulmonary embolism in both lungs as well as some older changes that were consistent with scar formations resulting from an infectious disease. A was started on Inhixa medication to treat the pulmonary embolism and was admitted into a ward for observation.

According to the epicrisis dated 3 June 2021 concerning the treatment period of 31 May to 3 June 2021, A was discharged after the ward stay. A three-month prescription was written for anticoagulant medication (enoxaparin, Inhixa). A was referred to the internal disease consultation polyclinic for a review of the tests on a predisposition to clotting and for further planning of the anticoagulant treatment. A was instructed not to take the second coronavirus vaccine shot while he was receiving active treatment for the pulmonary embolism.

According to the ‘B’ certificate written on 16 August 2021 based on telephonic contact, A explained that his state had not improved very much. He continued to get shortness of breath very easily. Because of the shortness of breath and easy bleeding, A had not been able to return to work at his warehouse job. The workplace is apparently quite an accident-prone environment, and A was worried about dangerous bleeding due to his anticoagulant medication. In laboratory tests, the coagulation factor FVIII was clearly elevated (305). The total cholesterol level was 5.9, and the LDL cholesterol level was 4.5. In order to make the anticoagulant treatment more effective, A was started on the cholesterol-lowering Rosuvastatin medicine in addition to Inhixa. A was given a medical certificate for sick leave from 5 July to 26 September 2021, and a consultation visit was programmed for clinical and symptom assessment.

According to the patient record entry by the internal disease emergency clinic dated 3 September 2021, A attended the emergency clinic because of shortness of breath symptoms, as these had worsened during exertion. Laboratory tests did not reveal anything out of the ordinary, and the cardiogram was normal. A was given a chest X-ray, which showed no changes compared to the previous X-ray. A was discharged.

According to the patient record entry by the coagulation disorder polyclinic dated 22 September 2021, A was given a blood count test whose results were normal with the exception of microcytosis, which had been first diagnosed several years ago. Electrolytes and liver function test results were also normal. In the blood coagulation system, the FVIII factor was at a high level (284). The LDL cholesterol level had gone down to 3.3. The anticoagulation medication was changed to Xarelto, and the patient was instructed to use this for the next three months. It was recommended that the patient should continue using the statin medication permanently. New laboratory tests (B-morpho, Hepar-TP and Hb-electrophoresis) were programmed for A, after which he would be contacted by telephone concerning the treatment.

Recommended solution

Formulation of the question

The case concerns the question of whether the pulmonary embolism in both lungs that A was diagnosed with on 31 May 2021 should be compensated as a pharmaceutical injury caused by the Comirnaty vaccine.

The applicable policy terms

According to the terms and conditions of the pharmaceutical insurance (effective from 1 January 2021), clause 4 (Pharmaceutical injury), a pharmaceutical injury means any physical illness, injury or mental disorder that was probably caused by a medicine – within the meaning of clause 2 of the terms and conditions – used by the injured party. (…)

Evaluation of the case

The pharmaceutical insurance covers any personal injuries that were probably caused by a medicine used by the injured party. This means that the injury may have several possible causes but the use of the medicine is the most likely cause, when all causes are considered as a whole. The evaluation of the causal connection takes into consideration the illness or injury treated with the medicine, any other illnesses and overall state of health of the compensation claimant, the treatments the claimant received and the medicine in question as well as any other medication the claimant had used. The causal connection is evaluated on the basis of medical knowledge and experience. A temporal connection alone, i.e. the fact that the symptoms appeared during or shortly after the use of the medicine, is not sufficient to prove a probable causal connection between the use of the medicine and the injury.

According to the information presented to the Insurance Complaints Board, A received the Comirnaty coronavirus vaccine on 21 May 2021. The following day, he developed a fever, which continued for approximately four days. On 30 May 2021, A attended the emergency department because of general weakness and fatigue, and on 31 May 2021 he was diagnosed with pulmonary embolism in both lungs, due to which the use of anticoagulant medication has been necessary for at least six months.

The Insurance Complaints Board observes that among coronavirus vaccines, the mRNA vaccines – such as the Comirnaty vaccine given to A – have not been associated with an increased risk of blood clots, unlike the adenovirus vector vaccines. In the light of current knowledge, a causal connection between the administering of the vaccine and the pulmonary embolism sustained by A is thus unlikely despite the temporal connection. On this basis, the Insurance Complaints Board considers the insurance company’s negative compensation decision to be in accordance with the terms and conditions of the insurance.

Final outcome

The Insurance Complaints Board does not recommend a change to the insurance company’s compensation decision.

The Insurance Complaints Board’s decision was unanimous.

THE INSURANCE COMPLAINTS BOARD

Char Norio                                              
Secretary Laine

Chair Members

Jokelainen
Järvinen
Mervaala
Soinila

Tulosta

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