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Administered by: Private Purchased by: Private
Life Threatening? No
Write-up: This is a spontaneous report from a contactable nurse practitioner via a company representative and from a healthcare professional on behalf of physician. A 17-year-old male patient received the first dose of TRUMENBA (lot number J28923, expiry date 30Jun2016) at 0.5 ml single, intramuscular, in left arm, on 09Dec2015 at 02:42 P.M. No other vaccine given along with the vaccine. Medical history included seasonal allergies. Concomitant medication included FLONASE daily (25 days), for 2 years. On 09Dec2015, the patient experienced achiness and extreme fatigue, raised area of redness around the injection site, 4x5 cm red/hot/tender area at vaccination site, that persisted for 48 hours with hot to touch and general lethargy. All these events recovered on 11Dec2015, Additionally it was reported that the patient did not feel on 09Dec2015 after noon but had to go back to school and then presented back at the office the next day. He could not concentrate to stay in school. On 10Dec2015 4x5 cm red/hot/tender area at vaccination site, extreme fatigue, body aches and weakness were noted. Outcome of feeling unwell, impaired concentration and vaccination site tenderness was unknown. On 10Dec2015 the patient had a flu test that resulted negative. The reporter felt that there was a causal relationship between the immunization and the reported side effects. Therapeutic measures included TYLENOL. The patient was not admitted to hospital. Follow-up (10Feb2016): New information from a contactable healthcare professional and nurse on behalf of physician includes: vaccination details, medical history, concomitant drug, additional events with relative details.
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