Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Generalised tonic-clonic seizure, Headache, Illness, Investigation, Malaise
Clinical narrative: Grand mal seizure; arm hurt; Headache; didn''t feel good; Low grade fever; throwing up and making God awful noises; sick; his fever broke and he got clammy and yucky after; his fever broke and he got clammy and yucky after; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent. A 13 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 20Jan2022 17:00 (Lot number: FJ1611) at the age of 13 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "seizure disorder petit mal" (unspecified if ongoing), notes: Verbatim: seizure disorder petit mal, states this was diagnosed back when he was 3; "Encopresis" (ongoing), notes: Verbatim: Encopresis, states he takes a laxative, Dulcolax, daily and he did have one that day and has been taking it for awhile, it's an ongoing battle.; "They upped his medication with weight gain so he was in good standing" (unspecified if ongoing), notes: They upped his medication with weight gain so he was in good standing. Concomitant medication(s) included: FLU, administration date 14Nov2021; DULCOLAX [BISACODYL] taken for encopresis (ongoing). Vaccination history included: Bnt162b2 (Dose 1st , had no side effects except his arm hurt. States he got it in his left arm at 5pm. Caller does not have NDC or expiry to provide. lot EW0182, Verbatim:his arm hurt), administration date: 13May2021, when the patient was 12 years old, for COVID-19 immunization, reaction(s): "his arm hurt", "His arm swelled up"; Bnt162b2 (Dose: 2nd, had no side effects except his arm hurt. States he got that in his left arm about 4pm. Caller does not have NDC or expiry to provide. lot EW0187., Verbatim:his arm hurt), administration date: 03Jun2021, when the patient was 12 years old, for COVID-19 immunization, reaction(s): "his arm hurt", "His arm swelled up". The following information was reported: GENERALISED TONIC-CLONIC SEIZURE (medically significant) with onset 21Jan2022 20:00, outcome "unknown", described as "Grand mal seizure"; PAIN IN EXTREMITY (non-serious) with onset 21Jan2022, outcome "unknown", described as "arm hurt"; HEADACHE (non-serious) with onset 21Jan2022, outcome "unknown", described as "Headache"; MALAISE (non-serious) with onset 21Jan2022, outcome "unknown", described as "didn''t feel good"; PYREXIA (non-serious) with onset 21Jan2022, outcome "unknown", described as "Low grade fever"; VOMITING (non-serious) with onset 21Jan2022, outcome "unknown", described as "throwing up and making God awful noises"; ILLNESS (non-serious) with onset 21Jan2022, outcome "unknown", described as "sick"; COLD SWEAT (non-serious), FEELING ABNORMAL (non-serious) all with onset 21Jan2022, outcome "unknown" and all described as "his fever broke and he got clammy and yucky after". The events "grand mal seizure", "arm hurt", "headache", "didn''t feel good", "low grade fever", "throwing up and making god awful noises", "sick", "his fever broke and he got clammy and yucky after" and "his fever broke and he got clammy and yucky after" were evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: blood glucose: (unspecified date) good; electroencephalogram: (27Jan2022) ok, notes: States his EEG came back ok; full blood count: (27Jan2022) good; investigation: (unspecified date) lower, notes: States it was lower the last 2 times they did it; (unspecified date) lower, notes: States it was lower the last 2 times they did it; (24Jan2022) 11.2, notes: It was a good level on Monday morning. Therapeutic measures were taken as a result of pyrexia. Clinical course: Caller states her son had a seizure, a grand mal seizure on the next day at about 8pm. Caller states he does have a seizure disorder petit mal and he has never had a grand mal before. States he is under the care of a neurologist and not that long ago they upped his medication with weight gain so he was in good standing. States all of a sudden, he said his arm hurt and he wanted her to come pick him up early from school so he didn't have to do gym with his arm hurting. States he complained of his arm hurting and he had a headache throughout the day and he didn't feel good and he laid down and fell asleep. Caller states she took his fever as it's common to have side effects of it and to be sick afterwards. States neither of them had side effects after the others. Caller states she was just checking to make sure he didn't get sick as it can happen and she kept checking for a fever and at one point it was a low grade fever and she just kept checking him. States at 8pm he got up from nap and he went back to his room and fell off his chair and she heard a bang and he was having a full blown grand mal seizure. States he busted his eye, it's black and blue as is his nose and he bit the heck out of his tongue and there was blood everywhere. Caller states she didn't know what was happening or where the blood was coming from. States he was throwing up and making God awful noises, it was horrible. Caller states she took him to the hospital. Caller states he did have a low grade fever and they gave him medication and his fever broke and he got clammy and yucky after. Caller states they sent him home 4 hours later and they increased his medication in case and did blood work and tested his blood sugar and that was all good. Caller states she took him in for another check of his medication level as if that is low that may trigger but those were fine. States his EEG came back ok. States that in her head and heart she feels it was the shot that did it, there is no other reason for it after getting all the stuff back. Caller states she prays to God he doesn't have another one. Investigations: States they did a Lamictal level, she thinks it was 11.2. States it was lower the last 2 times they did it and it was a good level on Monday morning, 24Jan2022. States they did blood work and an EEG on 27Jan2022. AE(s) following prior vaccinations: sore arm with dose 1 and 2 of Pfizer Covid shot. States he did have a reaction, his arm swelled up. States she thinks it was a reaction to one of his shots that was required for school and was told to ice it and take something. States it was nothing like serious.