Switzerland

General Information
The Table indicates the number of case reports entered into the PaniFlow database by health care professionals and not the total number of adverse reactions. The reports listed are only for suspected adverse events that meet certain criteria. A case may have one or more suspected adverse reactions, thus the number of reactions exceeds the number of case reports. Those reports that are not classified as serious are not listed separately, but are included in the total number of reports.

For pharmacovigilance purposes the term serious is defined as an event that is assessed to be medically important, or requiring (or prolonging) a hospital admission, or a persistent or significant disability, or a congenital birth defect, or life threatening or fatal. The term expected is defined as an event consistent with the description in the adverse reaction profile listed in the specified product monograph.

The following table and summary of suspected adverse reactions indicate the support and commitment of health care professionals to report to the PaniFlow system. Serious or unexpected reactions are reported on a timely basis and in sufficient detail.

Important:
The single case reports describe suspected adverse events that occurred in a close time period following vaccination. The cause of the suspected adverse event(s) cannot be immediately assigned based on a case report. The event(s) may be related to the vaccine, or the injection procedure, or may have occurred as a coincidence following the vaccination. Determining causality for suspected adverse events requires careful further assessment. A causal relationship with the vaccine cannot be established without a confirmed diagnosis and full investigations to identify other possible causes. 

Summary of reports of suspected adverse events following vaccination with pandemic influenza vaccines 

Comment:
There has been a steady decline in the number of new reports entered into PaniFlow since January 2010, likely corresponding to a decline in the number of new vaccinations. Since the last (8^th) report per 22.01.2010, 16 new reports have been registered in PaniFlow.

Swissmedic continues to encourage physicians and pharmacists to report suspected adverse events following vaccination. PaniFlow will remain available to receive reports online until 31 March 2010. The system can be reactivated at any time, according to the epidemiology of the influenza pandemic.

The Federal Office of Public Health (FOPH) has provided preliminary estimates of vaccine doses delivered and administered in Switzerland. As of 12.02.2010, a total of 2,949,250 vaccine doses were delivered to the 26 cantons (286,240 doses of Focetria®, 1,000,540 doses of Celtura®, 1,662,470 doses of Pandemrix®). The FOPH estimates that 14-20% of the Swiss population were administered the vaccines (estimates of doses given per vaccine are still pending). The midlevel in this range is thus about 1,3 million individuals having received vaccination against pandemic influenza in Switzerland..

Up to 12.02.2010, 524 reports have been registered by Swissmedic, the majority of adverse events reports received are self-limited reactions at the injection site, as well as generalized reactions such as headache, fever, muscle aches and joint pain. 55 reports for Focetria®, 30 reports for Celtura® and 439 reports for Pandemrix® have been filed. The overall reporting rate of adverse events to Swissmedic is thus about 40 per 100,000 vaccine doses administered). Swissmedic is continuously monitoring the vaccine batch numbers reported with the suspected adverse event; to date, no patterns have been observed.

The reported adverse reactions correspond with those described in clinical trials and with the profile from postmarketing experience with seasonal influenza vaccines. The reported adverse reactions of the pandemic influenza vaccines correspond to those observed in other countries using the same vaccine products.

Serious/medically important and expected reactions:
102 reports were classified as serious and expected. Most (65) reports were allergic reactions of varying severity. 5/65 patients had confirmed severe allergic symptoms with low blood pressure; these 5 patients received prompt medical care and the symptoms resolved. 15/65 reports described patients with other severe allergic reactions who received medical care and fully recovered. Severe allergic reactions may occur with any medication.

5/102 cases described severe systemic reactions (fever, chills, and muscle aches) with recovery. 4/102 cases reported joint aches and/or swelling around a joint. 3/102 cases described patients with uveitis treated with anti-inflammatory medications. 1/102 cases was reported as allergic vasculitis (without biopsy confirmation) in an older patient with history of rheumatological diseases, with good recovery after hospitalisation. Joint aches and swelling around joints are known and uncommon self-limited adverse reactions described in the product information for both seasonal and pandemic influenza vaccines. Vasculitis is also a known and very rare adverse event that has been described. In this case other diagnoses were not excluded.

12/102 cases described severe paraesthesias which were self-limited and 8/102 cases reported facial paralysis (Bell's palsy). Paraesthesias (tingling or numbing sensations) and facial palsy are adverse reactions associated with both pandemic and seasonal influenza vaccines and are usually self-limited conditions. 1/102 report was of a suspected increase in symptoms in a patient with pre-existing encephalopathy; in follow up with the reporting physician, these symptoms were transient and most likely reflected the natural fluctuation of a previously diagnosed condition.

Swissmedic has received 3 reports of suspected Guillain-Barré syndrome (GBS) meeting Brighton Collaboration diagnostic criteria and who are receiving care in hospital. It is important to note that GBS is a neurological condition that can occur in the absence of drug exposure and is more commonly associated with a recent infection. Swissmedic's PaniFlow database and other national pharmacovigilance databases in Europe and North America have not suggested that vaccines against pandemic influenza (H1N1) 2009 have contributed to the incidence of GBS.  

Each year, the background incidence of facial paralysis is more than 10 per 100,000 individuals and for GBS more than 1 per 100,000 individuals, with the natural occurrence of either condition increasing with age. A temporal relationship with vaccination may therefore be simply coincidental.

Serious/medically important and unexpected reactions:
130 reports were classified as serious and unexpected. 31/130 cases were medically important reactions that have been evaluated and assessed as unlikely to be related to the vaccination, due to other medical reasons and/or a temporal course that was implausible.  

12/130 cases described syncope (fainting) following vaccination related to the injection procedure. 1/130 cases described syncope and stroke-like symptoms following vaccination in a patient over 60 years of age. 1/130 cases described a febrile convulsion followed by good recovery in a 7-month old boy. A convulsion is a recognised complication of fever in young children. A non-febrile convulsion was described in 4/130 cases; 3 of the 4 patients had previously diagnosed brain diseases which were a risk for convulsion. 1 of the 4 patients had no history of epilepsy or known risk factors but the patient declined further medical investigation.

5/130 cases reported prolonged (> 1 month) muscle pains following vaccination, with 1/5 patient diagnosed with polymyalgia rheumatica, a condition with diffuse muscle tenderness. These cases are being followed closely.

5/130 reports described pregnancy losses in the first 20 weeks of gestation: 3 were spontaneous miscarriages in the first trimester, 1 case was an induced pregnancy loss for a genetic anomaly and 1 case was a loss due to an acute infectious process. 4/130 reports described intrauterine death more than 20 weeks in pregnancy. These cases have been investigated and indicated other plausible factors that may have led to the unfortunate event. An association with vaccination was assessed as unlikely in these 4 cases. 2/130 described vaccination early in the first trimester of pregnancy with no reported adverse effects, with follow up on the delivery planned.

14/130 reports described a death following vaccination. All cases reported serious underlying medical conditions unrelated with the vaccination. In all 14 cases an association with vaccination was assessed as unlikely.

Available mortality statistics indicate an average of 167 deaths per day in Switzerland and a background incidence rate of stillbirth of 4 per 1000 births in Western Europe. A temporal relationship with vaccination can therefore be simply coincidental.

In previous years, deaths have been reported to Swissmedic following seasonal influenza vaccination in Switzerland. Each of these reports is carefully investigated. In these cases, patients had serious underlying diseases such as heart or lung disease. A causal association with seasonal influenza vaccines and these reports was not established.

13/130 cases described an episode of arthritis in patients, with 8/13 having a pre-existing history of arthritis. 5/130 reports described multiple sclerosis: 2 individuals with new diagnoses and 3 individuals with known diagnoses of multiple sclerosis, with the patients responding to therapy. 13/130 cases reported herpes zoster (shingles) following vaccination. 6/130 cases described exacerbations of pre-existing conditions such as asthma and heart rhythm disturbances, with symptoms resolving after medical treatment. 2/130 cases described severe skin reactions (1 Stevens-Johnson syndrome and 1 acute generalised exanthematous pustulosis). Both patients were hospitalised and had good recovery. 3/130 cases described transient tinnitus, or reduced taste sensation or hearing loss. A causal association with the vaccine has not been established in these above cases.

Swissmedic has received 7 laboratory-confirmed cases of H1N1-viral infection and disease in patients who had been vaccinated with Pandemrix® (4 cases) or Focetria® (3 cases). 6/7 affected individuals had onset of symptoms more than 10 days following vaccination. Swissmedic encourages reports of laboratory-confirmed reports of viral infection with pandemic influenza (H1N1) 2009 following vaccination. Vaccine inefficacy is being closely monitored. It is noted that no vaccine or drug is 100% effective and worldwide there is currently no concern raised regarding the efficacy of H1N1 vaccines.

2/130 reports concerned abscesses or infection at the injection site following vaccination, which required and responded to antibiotic therapy. This highlights the importance of proper sterile technique in administering an injection.