Reporte zur Charge UP006AA

Symptomtext

Anaphylaxis; Initial information received on 17-Mar-2021 regarding an unsolicited valid serious courtesy case received from an other health care professional via consumer in the United States. This case involves a 68 years old female patient (166 cm and 81.65 kg) who experienced anaphylaxis (anaphylactic reaction), while she received MONOVALENT INFLUENZA A/H1N1 PRESERVATIVE VACCINE. The patient's medical history, past medical treatments, vaccinations and family history were not provided. At the time of the event, the patient had ongoing hypertension. On 27-Oct-2009, the patient received a dose of suspect MONOVALENT INFLUENZA A/H1N1 PRESERVATIVE VACCINE (batch number: UP006AA, expiry date: 15-MAR-2011) via an unknown route in unknown administration site for prophylactic vaccination. On an unknown date in Oct-2009, the patient experienced a serious anaphylaxis (anaphylactic reaction) after few days following the administration of MONOVALENT INFLUENZA A/H1N1 PRESERVATIVE VACCINE. This event was assessed as medically significant The event (Anaphylaxis) qualified for Adverse Event of Special Interest. It is unknown if the patient experienced any additional symptoms/ events. It is unknown if there were laboratories data/ results available. It was not reported if the patient received a corrective treatment for the event (Anaphylaxis). At time of reporting, the outcome of event anaphylaxis was unknown.; Sender's Comments: This case concerns a 68 years old female patient who experienced anaphylaxis few days after vaccination with MONOVALENT INFLUENZA A/H1N1 PRESERVATIVE VACCINE. The time to onset is compatible. The patient's medical condition at the time of vaccination was hypertension. However, lab tests were not reported. Based upon the reported information, the role of vaccine cannot be assessed.