Sex: M
Vaccine: FLUX, PPV, FLUX, PPV
Symptoms: Cardiac operation, Feeling abnormal, Head discomfort, Headache, Nausea
Clinical narrative: Sensitivity to flu or pneumococcal vaccines; Open heart surgery; Nauseated; Felt like his head would explode/headache; Was miserable; Fever goes to 104 (degrees Fahrenheit); This is a spontaneous case reported by other non-health professional to agency (reference number: SEQW20-00534) on 21-Jul-2020 and processed together with additional information received via Vaccine Adverse Event Reporting System (VAERS) (reference number: 872759-1) on 24-Jul-2020, concerning a male patient of unspecified age.  The patient's relevant medical history was not reported.  The patient's historical vaccines included unspecified influenza vaccines and pneumococcal vaccines after which the patient experienced severe sensitivity. The patient's concomitant medications were not reported.  On an unspecified date, the patient was administered INN Flu Vaccine Seasonal [Influenza virus vaccine polyvalent; dose, route of administration, anatomical location, batch number and expiration date: not reported] for an unknown indication.   On 15-Jun-2012, the patient was administered unspecified Pneumococcal vaccine [pneumococcal vaccine; dose, route of administration, anatomical location, batch number and expiration date: not reported] for an unknown indication.   On the same day, within 2 hours after vaccination, the patient experienced severe headache and a fever which went to 104 degrees Fahrenheit. The patient's head felt like it would explode, he felt miserable and nauseated.  On 16-Jun-2012, 12 hours later, the patient recovered from the events of headache, nauseated, feeling miserable' and 'fever'.  On an unspecified date, unknown amount of time after vaccination, the patient developed severe sensitivity.  On an unspecified date in 2019, during summer, the patient underwent open heart surgery. The additional information was not reported.  At the time of this report, the outcome for the events of open heart surgery' and hypersensitivity' was not reported.  Per company, the event of open heart surgery was considered as serious due to criterion of medical significance.  The reporter considered the event of hypersensitivity' as related to INN Flu Vaccine Seasonal and pneumococcal vaccine and did not provide causality assessment for other events.  The reporter did not provide consent to be contacted for follow up.  Company comment: The patient developed cardiac operation, nausea, hypersensitivity, headache, feeling abnormal and pyrexia unknown time after vaccination with the suspect product, INN Flu Vaccine Seasonal. Chronology is unclear. Causality may have been confounded by Pneumococcal vaccine. No information about medical history and concomitant medication was provided. Reportedly, the event of cardiac operation occurred approximately four years after the events nausea, headache, feeling abnormal and pyrexia, making temporal relationship implausible. Based on provided information, causal relationship between the suspect product and event of cardiac surgery is assessed as not related, due to temporal and biological implausibility, while for all other events as unassessable.; Sender's Comments: The patient developed cardiac operation, nausea, hypersensitivity, headache, feeling abnormal and pyrexia unknown time after vaccination with the suspect product, INN Flu Vaccine Seasonal. Chronology is unclear. Causality may have been confounded by Pneumococcal vaccine. No information about medical history and concomitant medication was provided. Reportedly, the event of cardiac operation occurred approximately four years after the events nausea, headache, feeling abnormal and pyrexia, making temporal relationship implausible. Based on provided information, causal relationship between the suspect product and event of cardiac surgery is assessed as not related, due to temporal and biological implausibility, while for all other events as unassessable.