Age: 13.0
Sex: F
Vaccine: FLU3, FLUN4, HPV9, FLU4, FLUN4, HPV4
Symptoms: Incorrect dose administered, Poor quality sleep
Clinical narrative: Based on additional information received on 01 July 2016, this case initially considered as non-serious was upgraded to serious Based on additional information received 01 July 2016, the report previously considered as non-valid became valid: patient identifier was reported. Initial unsolicited report received from a pharmacist on 29 April 2016. This is an invalid report as no patient identifiers were reported. It was reported that, a dose of Fluzone QIV (batch number: UI506AB, expiry date: 30 June 2016, dose, dose in series, route and site of administration were not reported); with a dose of FLUMIST (batch number: not reported, expiry date: not reported, dose, dose in series, via nasal route and site of administration not reported); with a dose of GARDASIL (batch number, expiry date, dose, dose in series, route and site of administration were not reported) all administered on 14 April 2016. Illness at the time of vaccination was reported as unknown, Pre-existing physician diagnosed allergies, birth defects, medical conditions were no known allergy (NKA). Concomitant medications were not reported. On 14 April 2016, 5-10 minutes after receiving FLUMIST in one nostril the patient had nose bleed. The patient experienced nose bleeding on 17 April 2016. On 18 April 2016 four days after vaccination had hemoptysis. On 26 April 2016, twelve days after vaccination had dizziness. The patient required ER/doctor visit. The patient's laboratory data and corrective treatment was not reported. The outcome of events was no reported. Follow up information received from a pharmacist on 01 July 2016. This case became valid. This case involves a 13-year-old female patient who was vaccinated with a dose of INFLUENZA QUADRIVAL A-B VACCINE (FLUZONE) injection by intramuscular route, second half dose of FLUMIST spray (Manufacturer: MED, Batch number, expiration date was not reported) in 1 nares in error and with a dose of GARDASIL (Manufacturer: MSD, batch number: L045700, expiry date, dose, dose in series and site of administration were not reported) injection by intramuscular route on 14 June 2016. Illness at the time of vaccination was reported as none. Patients pre-existing physician diagnosed allergies, birth defects, medical conditions included constipation, fatigue, heterozygous thalassemia and leg pain. It was reported that the patient did not received any other vaccinations within 4 weeks prior to 14 June 2016. On 15 June 2016, one day post vaccination, patient had nose bleed, hematemesis. On an unspecified date, patient had dizziness due to anemia (undiagnosed) and poor sleeping habits. The patient required ER/doctor visit for additional events. Laboratory investigations and corrective treatment were not reported. It was reported that dizziness continued 2 weeks later. On an unspecified date, patient was recovered from all the events. Upon internal review, the company decided to consider the event serious because of important medical event hematemesis. List of documents held by sender: none. Sender's Comments: Patient had hematemesis, hemoptysis, nose bleed, anemia and dizziness following INFLUENZA QUADRIVAL A-B VACCINE, FLUMIST and HUMAN PAPILLOMA VIRUS VACCINE. Patient is a known case of heterozygous thalassemia. This could be the underlying cause of anemia and dizziness in this particular case. As multiple vaccines were administered, the role of each vaccine cannot be assessed.