Sex: U
Vaccine: SMALL
Symptoms: Aphasia, Balance disorder, Brain oedema, Cardiac stress test, Cardiac stress test abnormal
Clinical narrative: Full stroke; Minute myocardial infarction; Complex Migraines; Little disoriented; Urine incontinency; Sensitivity to sounds; Fever; Complex headaches/ intense headaches; Photophobia; Nausea; A spontaneous report was received from a patient on 12OCT2022 and additional information was received on 20OCT2022 which upgraded the case to serious.  A 44-year-old female patient was diagnosed with "complicated migraines", "complicated headaches/intense headaches", "full stroke", and experienced "symptoms of residual stroke", "minute myocardial infarction", "photophobia", "fever", "nausea", was a "little disoriented", "urine incontinency", "swelling of the head/brain swelling", and "sensitivity to sounds" following immunization with ACAM2000 (lot number: unknown).  Medical history: Depression and "gastric issues" due to chronic treatment for headache and depression.  Concomitant medications: Emgality (galcanezumab), duloxetine, bupropion, omeprazole, naproxen, gabapentin, and Topamax (topiramate).  Allergies: none reported.  The patient reported that on an unknown date in SEP2008, she was administered ACAM2000 and has suffered from headaches since. Initially, the neurologists diagnosed her condition as "complex migraines" and then "complicated migraine" in 2016.  The patient complained of photophobia, fever, intense headaches, nausea, was little disoriented, had urine incontinency, swelling of the head, and sensitivity to sounds after the vaccination.  Furthermore, she described that when she gets episodes of headaches her head "gets really, really swelling." Treatment included gabapentin and Topamax for headaches, and naproxen every 4 hours for headaches, and fever. On an unknown date in 2009, the patient stated that she had recovered from the events of little disoriented and urine incontinency.  Later, on an unknown date in 2016, she experienced a "full stroke" and was hospitalized for 3 days.  While in the hospital, she received unknown treatment for her stroke and noted that she did not experience any debilitating effects from the stroke.  During her hospitalization, she also underwent a cardiac evaluation by a stress test, where a "minute myocardial infarction" was found, but her doctor was not concerned. The patient was discharged with a diagnosis of "complicated migraine", which she was referred to a neurologist and has been undergoing treatment for migraine.   She expressed that when she has migraine/headache "when her brain is "swollen" the oxygen supply to the brain is disrupted which can mimic stroke." Including headache, "problems with wordings," "forget things," "droopy eyes, droopy mouth," "all my right side of the body stop working," and "cannot even hold a glass of water from right hand." She also cannot write, has loss of spatial perception, which resulted in banging into objects. She experiences imbalance, has blurry "pixelated vision," and is unable to drive. Her neurologist stated that her stroke like symptoms is "from" the migraine headaches.  The patient was prescribed Emgality to treat her complex headaches/complex migraines, which she reported as "working better."  Patient had been to the emergency room (ER) multiple times where she received intravenous (IV) medications and a combination of medications, and the ER would discharge her when she was stabilized.  The outcome of the events symptoms of residual stroke, photophobia, sensitivity to sound, and "brain swelling" are all ongoing. The outcome of the events complex migraines and headache are recovering/resolving. The outcome of the events urinary incontinence, acute myocardial infarction, disoriented, fever, and nausea are all recovered/resolved. The outcome of the event full stroke was not reported.   Company comment:  Complex migraines are not a known phenomenon of ACAM2000, the events reported show no temporal relation due to reporting dates and administration of vaccine; Therefore, considered not related. The migraine induced stroke in 2016 was not due to ACAM2000, which provides a more plausible reason.  Due to the long period between occurrences the sequencing of events may have been mis associated between migraine and stroke like symptoms can be related to both diagnoses.  The event in 2016 of myocardial infarction was an incidental finding with no concern, also unrelated. The case is considered serious due to hospitalization.; Sender's Comments: Complex migraines are not a known phenomenon of ACAM2000, the events reported show no temporal relation due to reporting dates and administration of vaccine; Therefore, considered not related. The migraine induced stroke in 2016 was not due to ACAM2000, which provides a more plausible reason.  Due to the long period between occurrences the sequencing of events may have been mis associated between migraine and stroke like symptoms can be related to both diagnoses.  The event in 2016 of myocardial infarction was an incidental finding with no concern, also unrelated. The case is considered serious due to hospitalization