Age: 7.0
Sex: F
Vaccine: FLUN4
Symptoms: Abdominal pain upper, Cyanosis, Drug ineffective, H1N1 influenza, Malaise
Clinical narrative: A spontaneous report has been received from a consumer concerning an 8 year old, female patient. No information regarding the relevant history, concomitant disease and concomitant drug was provided. Patient received nasal FLUMIST QUADRIVALENT (intranasal) on Nov-2015, 0.2 millilitres, unknown for prevent H1N1 and flu vaccination. It was reported that the patient received FLUMIST QUADRIVALENT vaccination in November-2015, but fell ill in February. Patient woke up on 14-February-2016 with a stomachache and had fingers and toes turned blue (preferred term: skin discolouration) and patient died suddenly from H1N1 (Preferred Term: H1N1 influenza), also known as swine flu both versions of FDA-approved FLUMIST QUADRIVALENT were supposed to prevent H1N1. CDC voted against using FLUMIST QUADRIVALENT this winter after studies found no protective benefit could be measured (Preferred Term: Drug ineffective) with three percent effectiveness CDC recommends traditional flu shot instead, which had an estimated effectiveness of 63 percent for children between the ages of two and 17. Patient's parents are stunned by the CDC's vote, saying they trusted their doctor's recommendations. It was not known if this was the only dose she received. On 14-Feb-2016 the patient woke up with a stomach ache and died hours later (Preferred Term: Abdominal pain upper). Cause of death were H1N1, woke up with a stomach ache and died hours later/ stomachache and no protective benefit could be measured. It was unknown if autopsy was performed. The outcome of the event of fingers and toes turned blue was unknown. The company physician considered the events H1N1, no protective benefit could be measured and woke up with a stomach ache and died hours later/ stomachache to be serious due to fatal outcome. The reporter considered the event fingers and toes turned blue to be non-serious. The company physician suggested to not capture ill as an event. Corrected report 15-Sep-2016: Suspect product was corrected. Country of case and country of reporter was corrected. Narrative corrected. Summary of follow-up information received by AstraZeneca/MedImmune on 12-Sep-2016 from consumer: Event verbatim updated from woke up with a stomach ache and died hours later/ stomachache to stomachache. Seriousness criteria updated for event woke up with a stomach ache and died hours later/ stomachache to died from non serious. Indication added. Dosing regimen updated. Reporter details updated. Associated case ID added. Patient date of birth added. Narrative corrected. Sender's Comments: Fatal events of H1N1 influenza and Abdominal pain upper are not listed in the company core data sheet for FLUMIST QUADRIVALENT. Drug ineffectiveness was also reported. No vaccine is 100% effective, so occasional vaccine failures may be expected. Drug ineffectiveness could contribute to H1N1 influenza. However there is insufficient information on patient's relevant medical history, concurrent diseases, concomitant medication, diagnostic workup and autopsy results which makes causal relationship difficult to assess.; Reported Cause(s) of Death: H1N1; NO PROTECTIVE BENEFIT COULD BE MEASURED; WOKE UP WITH A STOMACH ACHE AND DIED HOURS LATER/ STOMACHACHE.