Sex: F
Vaccine: FLUX, UNK
Symptoms: COVID-19, Dehydration, Headache, Illness, Migraine
Clinical narrative: Migraines; dehydration; sick from Flu shot; headache/pain in the head; Covid; This case was reported by a consumer via licensee and described the occurrence of migraine in a 69-year-old female patient who received botulinum toxin type a powder for injection for product used for unknown indication.   Co-suspect products included Flu unspecified (Influenza vaccine) for prophylaxis.   Concurrent medical conditions included insulin resistance and cholesterol.   On an unknown date, the patient started botulinum toxin type a (unknown) at an unknown dose and frequency and Influenza vaccine. In January 2020, unknown after receiving botulinum toxin type a and Influenza vaccine, the patient experienced covid-19 and headache. On an unknown date, the patient experienced migraine (serious criteria hospitalization), dehydration (serious criteria hospitalization) and sickness. On an unknown date, the outcome of the headache, migraine, dehydration and sickness were unknown and the outcome of the covid-19 was recovered/resolved.   It was not reported if the reporter considered the migraine, dehydration, covid-19, sickness and headache to be related to botulinum toxin type a. It was unknown if the reporter considered the migraine, dehydration, covid-19, sickness and headache to be related to Influenza vaccine.     GSK Receipt Date:12-JUL-2022 Case received via Allergen . Allergen received case 12-JUL-2022 and subsequently forwarded to GSK on 20-JUL-2022 Dechallenge and Rechallenge for Non-Company suspect product was not applicable kept in narrative as it leads to validation failure. Narrative information received: An initial Sponsored Study report was received on 12-JUL-2022 regarding a 69-year-old female patient.  The patient's concomitant disease included ongoing "Insulin resistance" (Insulin resistance) and "Cholesterol disorder" (Blood cholesterol) since an unknown date. The patient was hospitalized for 4 days with migraines and dehydration after not being able to pay for the medication. No known number of units. Therapy started 2-3 years. Other medications were included a list of things for cholesterol and stroke risk, she was also insulin resistant.  On an unknown date in JAN-2020, she had COVID and had bad headaches with Covid, and severe pain in the head. She was recently tested and was still showing antibodies in Oct or Nov 2020. She get sick from the flu shot. The reporter did not provide a causality assessment between the events of dehydration, migraine, cOVID-19, illness, and headache and BOTULINUM TOXIN TYPE A - GENERAL. Allergan assessed the relationship between BOTULINUM TOXIN TYPE A - GENERAL and the event of migraine as not assessable. Allergan assessed the relationship between BOTULINUM TOXIN TYPE A - GENERAL and the events of dehydration, cOVID-19, illness, and headache as not related.    On an unknown date in 2022, relevant laboratory and diagnostics tests included SARS-CoV-2 antibody test. The SARS-CoV-2 antibody test results were: positive.    Treatment information was not provided. On an unknown date, the patient recovered from covid-19. At the time of the report, the outcomes of dehydration, migraine, illness, and headache were reported as unknown.  Follow-up has been performed for this case and a response is pending. Serious Event(s): Migraine; Dehydration; Sender's Comments: Considering the inconsistency with pharmacological effects, there is no reasonable possibility that dehydration and Covid-19 are related to the suspect drug. Due to limited information, the event of migraine is not assessable. There is no reasonable possibility that illness and headache are related to the suspect drug. The events are more likely related to Influenza vaccine and respectively to Covid-19.