Sex: F
Vaccine: FLUX
Symptoms: Anaemia, Drug interaction, Ecchymosis, Haematoma, International normalised ratio increased
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, 2018SA096354, 2018SA096379, 2018SA096401, 2018SA096428, 2018SA096432, 2018SA096439, 2018SA096448, 2018SA096456, 2018SA096464, 2018SA096471, 2018SA096475, 2018SA096477, 2018SA096479, 2018SA096482, 2018SA096366, 2018SA096377, 2018SA096413, 2018SA096421, 2018SA096433, 2018SA096450, 2018SA096460, 2018SA096465, 2018SA096469, 2018SA096473, 2018SA096478, 2018SA096483, 2018SA096485, 2018SA096488, 2018SA096500, 2018SA096502, 2018SA096505, 2018SA096506, 2018SA096508, 2018SA096383, 2018SA096338 (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 dataBase, 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 database were included in our analysis; antiepileptics and statins were related to the highest number of indeterminate/consistent (93.7%; 65.3%) and possible/probable (50%; 57.7%) 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 78-year-old female patient who was vaccinated with dose of INFLUENZA VACCINE (INACTIVATED, SPLIT-VIRUS INFLUENZA VACCINE) and received Warfarin, Clopidogrel, RAMIPRIL, METOPROLOL, ENOXAPARIN, SIMVASTATIN, ITRACONAZOLE and ACETYLSALICYLIC ACID (batch number, expiry date, route and site of administration were not reported) on an unknown date. The patient's predisposing conditions included Coronary artery disease, aortic valve replacement and hypertensive heart disease. Other medical history were not reported. On an unspecified date, on the same day post vaccination and post drug administration, the patient developed anemia, ecchymosis, hematoma, pain in extremity and peripheral swelling. On an unknown date, the patient was hospitalized. Authors pointed out that suspect drugs Warfarin and Clopidogrel are known to have drug-drug interactions. Relevant laboratory investigation showed PT and INR increased. Corrective treatment were not reported. The outcome of the events was not reported. The reporter assessed the causal relationship with INFLUENZA VACCINE and Warfarin as inconsistent not applicable. Additional information downloaded from database (level 2B) was received from literature (under the reference number: IT-BRISTOL-MYERS SQUIBB COMPANY-BMS-2018-033440) on 16-Apr-2018. On an unknown date, following vaccination, the patient experienced drug-vaccine interaction. The Pharmaceutical Company and reporter assessed the causal relationship with CLOPIDOGREL and Ecchymosis as related. The Pharmaceutical Company and reporter assessed the causal relationship with WARFARIN and Ecchymosis as related. Additional information downloaded from database (level 2B) was received from literature via other company (under the reference number: IT-BRISTOL-MYERS SQUIBB COMPANY-BMS-2018-033444 and GB-BRISTOL-MYERS SQUIBB COMPANY-BMS-2008-000058 on 08-Jun-2018. Sender's Comments: This patient was hospitalized due to multiple events while on multiple suspect drugs including aspirin and influenza virus vaccine. The drug-vaccine interaction was reported; and this interaction was considered related. Intake of co-suspect influenza virus vaccine and simvastatin were likely could have contributed to rhabdomyolysis; Based on the etiopathogenesis of skin candida infection; and these events were considered not related to aspirin. Additional information downloaded from database (level 2B) was received from literature via other company (under the reference number: IT-BRISTOL-MYERS SQUIBB COMPANY-BMS-2018-033444 and GB-BRISTOL-MYERS SQUIBB COMPANY-BMS-2008-000058 on 29-Jun-2018. Suspect Drug has been updated. Additional information downloaded from database (level 2B) was received from literature via other company (under the reference number: IT-EMA-DD-20180724-pagraharip-112516) on 09-Aug-2018. No new information reported. List of documents held by sender: none.; Sender's Comments: Follow up received on 09-AUG-2018 does not change the previous assessment. This elderly patient with medical history of heart diseases, developed reported events following vaccination with Influenza vaccine (unknown manufacturer). Time to onset is unknown. Additional information including vaccination details with manufacturer, onset time, concomitant vaccinations, past vaccination history with tolerance data lab test ruling out other infectious etiology is needed for further assessment. Based on available information role of vaccine cannot be assessed. 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