Sex: U
Vaccine: COVID19, COVID19, FLUX, VARZOS
Symptoms: Brain oedema, Fatigue, Hypersensitivity, Somnolence
Clinical narrative: experienced the symptoms of brain swelling; Very little, very minor, just tiredness until that time/Extreme tiredness; allergic reaction to a histamine or barbital ingredient; slept for almost 24 hours on and off; This serious case was reported by a consumer via other manufacturer and described the occurrence of brain swelling in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included TOZINAMERAN (COVID 19 VACCINE PFIZER) for prophylaxis, INFLUENZA VACCINE (INFLUENZA VACCINE UNSPECIFIED) for prophylaxis, TOZINAMERAN (COMIRNATY PFIZER) for prophylaxis and barbital for product used for unknown indication.   Previously administered products included Barbital.   On an unknown date, the patient received Shingrix, COVID 19 VACCINE PFIZER, INFLUENZA VACCINE UNSPECIFIED, COMIRNATY PFIZER and barbital. On an unknown date, an unknown time after receiving Shingrix, the patient experienced brain swelling (Verbatim: experienced the symptoms of brain swelling) (serious criteria GSK medically significant), tiredness (Verbatim: Very little, very minor, just tiredness until that time/Extreme tiredness), sleepiness (Verbatim: slept for almost 24 hours on and off) and allergic reaction (Verbatim: allergic reaction to a histamine or barbital ingredient). The action taken with barbital was unknown. In OCT-2023, the outcome of the sleepiness was resolved (duration 24 hrs). The outcome of the brain swelling and tiredness were unknown and the outcome of the allergic reaction was not reported.   It was unknown if the reporter considered the brain swelling, tiredness, sleepiness and allergic reaction to be related to Shingrix.     It was unknown if the company considered the brain swelling, tiredness, sleepiness and allergic reaction to be related to Shingrix.   Additional Information: GSK Receipt date: 27-OCT-2023 The patient was self-reported. The patient states that he/she did not have any flu reaction at all and what he/she had was like an allergic reaction to a histamine or barbital ingredient and it causes brain swelling and he/she had a pretty severe reaction. (Intent: History). So, he/she wanted to know was there any barbital in the medication for the push system. The patient stated his/her current vaccination was on Tuesday. When clarified if consumer had taken barbital: Consumer stated, yes, they are everything from caffeine to morphine. So, he/she had to be very careful but he/she did not expected it in the vaccination.  But he/she think there was one, because he/she only get that reaction with that (Barbital) thing and he/she trying to find what it was. So, he/she know if he/she didn't take it again. The patient stated, Very little, very minor, just tiredness until that time. But he/she took three vaccinations all at the same time, he/she took Shingrix, Pfizer Covid vaccine and also take the flu (Unspecified Flu Vaccine). The patient stated, Extreme tiredness, he/she slept for almost 24 hours on and off and experienced the symptoms of brain swelling and he/she just trying to figure out was that because he/she took three at the same time, which he/she had not done before and also need to know if they had barbital in them at all and it was not just a medicine but it was a push and he/she want to know the name of the push. It was unknown if the reporter considered the brain swelling, tiredness, sleepiness and allergic reaction to be related to Flu vaccine, covid vaccine, Comirnaty and barbital.    The patient stated, No he/she do not had time right now but you can call his/her back later if you wish.