Sex: M
Vaccine: FLUX
Symptoms: Sensory disturbance
Clinical narrative: Initial unsolicited report received from literature on 26 Mar 2018. This case was linked to 2018SA095111, 2018SA095117, 2018SA095112, 2018SA095116, 2018SA096247, 2018SA096279, 2018SA096286, 2018SA096304, 2018SA096332, 2018SA096338, 2018SA096354, 2018SA096379, 2018SA096401, 2018SA096428, 2018SA096432, 2018SA096439, 2018SA096456, 2018SA096464, 2018SA096468, 2018SA096471, 2018SA096475, 2018SA096477, 2018SA096479, 2018SA096366, 2018SA096377, 2018SA096413, 2018SA096421, 2018SA096450, 2018SA096460, 2018SA096465, 2018SA096473, 2018SA096478, 2018SA096483, 2018SA096485, 2018SA096500, 2018SA096502, 2018SA096505, 2018SA096506, 2018SA096508, 2018SA096383, 2018SA096433, 2018SA096488, 2018SA096469, 2018SA096448 (Same Literature). The following is verbatim from the article: Background: An increasing number of reports indicates that vaccines against influenza may interact with specific drugs via drug metabolism. To date, actual impact of vaccine-drug interactions observed in the real world clinical practice has not been investigated. Methods: From VAERS and VigiBase, we collected Adverse Event Following Immunization (AEFI) reports for individuals receiving vaccines against influenza recorded as suspect and selected cases where predictable toxicity was recorded with oral anticoagulants, antiepileptics and statins (i.e. hemorrhages, overdosage and rhabdomyolysis, respectively). We applied AEFI and Drug Interaction Probability Scale (DIPS) Algorithms to assess causality of drug-vaccine interactions. Results: 116 AEFI reports submitted to VAERS and 83 from Vigibase were included in our analysis; antiepileptics and statins were related to the highest number of indeterminate/consistent (93.7 percent; 65.3 percent) and possible/probable (50 percent; 57.7 percent) cases according to the AEFI and DIPS, respectively. The majority of cases occurred within the first week after vaccine administration (5-7 days). Conclusion: The relative paucity of detected interactions does not impact on the benefit of the vaccination against influenza, which remains strongly recommended; this does not exclude that closer monitoring for selected patients exposed to concomitant chronic pharmacological therapies and affected by predisposing factors may be useful. This case involves a 65-year-old male patient who was vaccinated with dose of INFLUENZA VACCINE (TRIVALENT INACTIVATED SUBUNIT INFLUENZA VIRUS VACCINE) (batch number, expiry date, route and site of administration were not reported) and received Simvastatin (batch number and expiry date were not reported) on an unknown date and the patient was also received omeprazole, diclofenac, Dextropropoxyphene, acetaminophen and codeine on an unknown date. The patient's medical history included arthritis. Concomitant medications included Tamsulosin. On an unspecified date, 29 days post vaccination and post drug administration, the patient developed Blood creatine phosphokinase increased, infection leukocytosis, pain, rhabdomyolysis, sensory disturbance. On an unknown date, the patient was hospitalized. Authors pointed out that suspect drugs omeprazole, diclofenac, Dextropropoxyphene, acetaminophen and codeine are known to have drug-drug interactions. Lab test CPK showed 39500 (unit reported). Corrective treatment was not reported. The outcome of the events was not reported. The reporter assessed the causal relationship with INFLUENZA VACCINE and Simvastatin as inconsistent not applicable as per drug interaction probability scale. Additional information downloaded from regulatory authority database was received from other healthcare professional on 13-Aug-2018. Sender's comment: In the absence of information regarding concomitant medication details, events details including exact onset date, relevant laboratory details and therapy details for all the suspect drugs with start date, the causality for the reported events not assessable for the Novartis suspect drugs. List of documents held by sender: none. Sender's Comments: Follow-up report received on 13-AUG-2018 doesn't change the previous assessment for the case; Patient developed Rhabdomyolysis, increased CPK levels, leukocytosis and sensory disturbance after vaccination. Time to onset is compatible. Patient was also on simvastatin, acetaminophen, omeprazole, diclofenac. Further information regarding vaccination details (MFR), symptoms and their evolution, medical history as well as concurrent condition during vaccination, previous vaccination and tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. There is a possibility that the events might be related to other drugs mentioned. Based upon the given information the role of the vaccine cannot be assessed. US-SA-2018SA095111:CLUSTER; IT-SA-2018SA096433:CLUSTER; IT-SA-2018SA096477:CLUSTER; IT-SA-2018SA096338:CLUSTER; IT-SA-2018SA095116:CLUSTER; IT-SA-2018SA095111:CLUSTER; IT-SA-2018SA096421:CLUSTER; IT-SA-2018SA096448:CLUSTER.