Sex: F
Vaccine: RAB
Symptoms: Migraine with aura, Nausea, Presyncope, Pyrexia, Vomiting
Clinical narrative: did not feel "back to normal"; Migraine with aura; condition aggravated; Felt like she was going to pass out; Chills; nausea; pyrexia; vomiting; Fatigue; Case reference number BN-2021-002449, initially downloaded on 22-Nov-2021, is a spontaneous case report received from a consumer/non-health professional via health authority (Safety report ID 1745676-1) and concerns a 34-year-old female patient.  The patient's medical history included history of migraines, EDS (Ehlers-Danlos syndrome), asthma and allergy on penicillin.  The patient's concomitant medication details were not provided.  On an unspecified day, the patient received the first dose of Rabipur (Inactivated Rabies Virus Vaccine, Batch no. not provided) at an unknown dose and route of administration, for unknown indication.  On 15-Sep-2021, the patient received the second dose of Rabipur (Inactivated Rabies Virus Vaccine, Batch no. ARBA801B) at an unknown dose, intramuscularly in right arm for unknown indication. On the same day, about eight hours after the injection, the patient developed intense fatigue.  , On an unspecified date, also reported as the following morning, the patient experienced debilitating migraine with aura accompanied by nausea/vomiting ("I couldn't keep anything down") and dizziness. The patient felt like was going to pass out two times but never fainted. The patient experienced fever and chills as well. Worst of symptoms lasted 24 hours, but it was stated the patient did not feel "back to normal" for three or four days. It was also stated that the patient did not have success in past finding medications to treat/prevent her migraines.  On an unspecified day, the patient was recovered from all the events.  The reporter assessed all the events as non serious. Causality assessment was not provided.  No further information was provided.; Reporter's Comments: The 34-year-old female patient received the first and the second dose of Rabipur for unknown indication. Reportedly, on the day 0 after the second dose, the patient experienced non-serious event of fatigue. On the following morning, the patient experienced non-serious events of migraine with aura, nausea, vomiting, dizziness, fever, chills, feeling abnormal and condition aggravated, as reported. The events of fatigue, nausea, vomiting, dizziness, fever and chills are listed for Rabipur according to Datasheet V6, whilst the events of migraine with aura, feeling abnormal and condition aggravated are not listed for Rabipur according to the Datasheet V6. The patient's medical history included migraines and EDS (Ehlers-Danlos syndrome). The patient's concomitant medication details were not provided. The outcome of events was recovered/resolved. The patient's conditions of migraines and Ehlers-Danlos syndrome confounded the causality for the events. The event of migraine with aura has been considered as not related to Rabipur, but to a patient's condition of migraine. Considering plausible temporal relationship and known vaccine safety profile, the events of fatigue, nausea, vomiting, dizziness, fever and chills have been considered as related to Rabipur. Considering plausible temporal relationship and since contributory role of the suspect vaccine cannot be excluded, the events of feeling abnormal and condition aggravated have been considered as related to Rabipur. This case is considered as non-serious.; Sender's Comments: The 34-year-old female patient received the first and the second dose of Rabipur for unknown indication. Reportedly, on the day 0 after the second dose, the patient experienced non-serious event of fatigue. On the following morning, the patient experienced non-serious events of migraine with aura, nausea, vomiting, dizziness, fever, chills, feeling abnormal and condition aggravated, as reported. The events of fatigue, nausea, vomiting, dizziness, fever and chills are listed for Rabipur according to Datasheet V6, whilst the events of migraine with aura, feeling abnormal and condition aggravated are not listed for Rabipur according to the Datasheet V6. The patient's medical history included migraines and EDS (Ehlers-Danlos syndrome). The patient's concomitant medication details were not provided. The outcome of events was recovered/resolved. The patient's conditions of migraines and Ehlers-Danlos syndrome confounded the causality for the events. The event of migraine with aura has been considered as not related to Rabipur, but to a patient's condition of migraine. Considering plausible temporal relationship and known vaccine safety profile, the events of fatigue, nausea, vomiting, dizziness, fever and chills have been considered as related to Rabipur. Considering plausible temporal relationship and since contributory role of the suspect vaccine cannot be excluded, the events of feeling abnormal and condition aggravated have been considered as related to Rabipur. This case is considered as non-serious.