Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling, Urticaria
Clinical narrative: Significant hypersomnia, cataplexy; Significant hypersomnia, cataplexy; Significant hypersomnia/diagnosed as (autoimmune) Narcolepsy; Severe food intolerances/allergies/reactions to all foods containing DSPC; Severe food intolerances/allergies/reactions to all foods containing DSPC; urticaria/occasional urticaria; pruritus; swelling; acute sleepiness; nausea; diarrhea; hypotension; This is a spontaneous report received from an Other HCP.  A 23-year-old female patient (not pregnant) received BNT162b2 (COMIRNATY), on 30Sep2021 as dose 3 (booster), single (Lot number: 301558A) at the age of 23 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "tree nuts" (unspecified if ongoing), notes: Prior to adverse event; "allergic to a handful of produce" (unspecified if ongoing), notes: Prior to adverse event; "Allergic rhinitis" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "ADHD" (unspecified if ongoing); "Hypermobile Ehlers Danlos Syndrome" (unspecified if ongoing); "Fibromyalgia" (unspecified if ongoing); "PCOS" (unspecified if ongoing); "Hashimoto's thyroiditis" (unspecified if ongoing); "childhood epilepsy" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE; UNKNOWN MANUFACTURER), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE; UNKNOWN MANUFACTURER), for COVID-19 immunization. The following information was reported: FOOD INTOLERANCE (disability), FOOD ALLERGY (disability) all with onset 30Sep2021, outcome "not recovered" and all described as "Severe food intolerances/allergies/reactions to all foods containing DSPC"; CATAPLEXY (disability), HYPERSOMNIA (disability) all with onset 30Sep2021, outcome "not recovered" and all described as "Significant hypersomnia, cataplexy"; NARCOLEPSY (disability) with onset 30Sep2021, outcome "not recovered", described as "Significant hypersomnia/diagnosed as (autoimmune) Narcolepsy"; SOMNOLENCE (disability) with onset 30Sep2021, outcome "not recovered", described as "acute sleepiness"; DIARRHOEA (disability) with onset 30Sep2021, outcome "not recovered", described as "diarrhea"; HYPOTENSION (disability) with onset 30Sep2021, outcome "not recovered"; NAUSEA (disability) with onset 30Sep2021, outcome "not recovered"; PRURITUS (disability) with onset 30Sep2021, outcome "not recovered"; SWELLING (disability) with onset 30Sep2021, outcome "not recovered"; URTICARIA (disability) with onset 30Sep2021, outcome "not recovered", described as "urticaria/occasional urticaria". Therapeutic measures were taken as a result of cataplexy, hypersomnia, narcolepsy, food intolerance, food allergy, urticaria, pruritus, swelling, somnolence, nausea, diarrhoea, hypotension.  Clinical course: The patient experienced significant hypersomnia, cataplexy diagnosed as (autoimmune) Narcolepsy which was likely brought out by booster. The patient also had severe food intolerances/allergies/reactions to all foods containing DSPC (which can be found in over 400 plant foods). In the months following this vaccination, the patient developed significant allergic-like reactions (urticaria, pruritus, swelling, etc.) to plant foods (fruit, vegetable, nuts, seeds, grains, and soy). After extensive research, the patient and her medical team discovered that the sensitized foods all contain DSPC, one of the vaccine excipients/inactive ingredients. After being on omalizumab for the last 2 years (again, thinking this was food allergy), the patient's reactions persist; however, the reactions no longer appear allergic-like and now were much more atypical (acute sleepiness, nausea, diarrhea, cataplexy, hypotension, and occasional urticaria). The patient's medical team believed that she was sensitized to DSPC following the booster. The treatment of the events included over 10+ medications, including omalizumab.; Sender's Comments: Based on the close temporal association, there is reasonable possibility of causal association between the Reported events Cataplexy, Hypersomnia, Narcolepsy, Urticaria, Pruritus, Swelling, Somnolence, Nausea, Diarrhoea, Hypotension, Food intolerance, Food allergy and the suspect drug The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.