Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Acute onset left mandibular and periauricular swelling, which is over the left parotid gland in the left cheek that had acute onset of swelling and pain; Acute onset left mandibular and periauricular swelling, which is over the left parotid gland in the left cheek that had acute onset of swelling and pain; booster; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the parent.  A 11 year-old male patient received bnt162b2 (BNT162B2), administered in deltoid left, administration date 20Dec2021 11:30 (Lot number: PE3590) at the age of 11 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "History of right paratitus", start date: Jan2020 (unspecified if ongoing); "21q chromosome deletion syndrome" (unspecified if ongoing), notes: congenital abnormality, born with that;; "Frequent hospitalizations for aspiration pneumonia" (unspecified if ongoing); "Epilepsy seizures", start date: 2010 (unspecified if ongoing); "Chronic asthma" (ongoing); "Left side plural effusion diagnosed by CT scan", start date: 05Dec2021 (unspecified if ongoing), notes: Completed 10 day Clindamycin (05Dec2021) w/ complete resolution by chest x-ray (20Dec2021); "Penicillin allergy", start date: 2010 (ongoing), notes: Rash allergy; pretty early on; they actually tested him again and proved he was still allergic.; "Diffuse polymicrogyria" (unspecified if ongoing), notes: Associated with 21q chromosome deletion syndrome.; "Microcephaly" (unspecified if ongoing), notes: Associated with 21q chromosome deletion syndrome.; "G-tube surgery", start date: Jun2010 (unspecified if ongoing); "Atrial septal defect (ASD) cardiac repair", start date: Nov2012 (unspecified if ongoing); "Vagal nerve stimulator (ventral amygdalofugal pathway-VAF) for placement for seizures", start date: Jul2015 (unspecified if ongoing); "Bilateral elective orthopedic hip surgery", start date: Oct2018 (unspecified if ongoing); "Percutaneous drainage for kidney stone removal", start date: Nov2019 (unspecified if ongoing); "Chronic persistent ear infections", start date: Aug2021, stop date: Oct2021, notes: finally resolved.; "Presumed left lower lobe pneumonia", start date: Nov2021 (unspecified if ongoing), notes: with Cefdinir-want to say in Nov2021.; "Horseshoe kidney" (unspecified if ongoing); "History of calcium oxalate kidney stones" (unspecified if ongoing), notes: This is due to his anatomic abnormality with horseshoe kidney.; "Non-verbal" (unspecified if ongoing); "Seizures" (ongoing); "Hypertonia" (ongoing); "Spasticity" (ongoing); "Sleep disorder" (ongoing); "GI dysmotility" (ongoing); "To control and decrease oral secretions" (ongoing); "to reduce the risk of aspiration" (ongoing); "Frequent hospitalizations for aspiration pneumonia" (unspecified if ongoing). No prior vaccination (within four weeks) prior to the first administration date of the suspect vaccine. No family medical history relevant to AEs, no one has had any reactions, no egg allergies, no vaccine reactions, nothing. Concomitant medication(s) included: DEPAKOTE taken for seizure (ongoing); CLOBAZAM taken for seizure (ongoing); FELBAMATE taken for seizure (ongoing); BACLOFEN taken for hypertonia, muscle spasticity (ongoing); SINGULAIR taken for asthma (ongoing); TRAZODONE taken for sleep disorder (ongoing); SCOPOLAMINE [HYOSCINE] taken for oral discharge, aspiration (ongoing); LEVALBUTEROL [LEVOSALBUTAMOL] (ongoing); BUDESONIDE (ongoing); IPRATROPIUM (ongoing); VITAMIN C [ASCORBIC ACID] taken for supplementation therapy (ongoing); VITAMIN D3 taken for supplementation therapy (ongoing); PROBIOTICS taken for supplementation therapy (ongoing); MIRALAX taken for gastric disorder (ongoing); CLINDAMYCIN taken for pleural effusion, start date: 05Dec2021, stop date: 15Dec2021. Past drug history included: Botox, start date: 06Oct2021, for Botox administration to his salivary glands bilaterally, notes: Additional Information for Other Conditions: Performed to decrease oral secretions. That is first time they have done this. Vaccination history included: Bnt162b2 (Dose: 01, Lot: EW0179, Dose: Adult dose for ages 12 and over, exact strength/volume unknown-administered via injection to deltoid muscle, unknown if right or left side.), administration date: 15May2021, when the patient was 11 years old, for Covid-19 Immunization, reaction(s): "Patient adminsitered the first 2 doses of the Pfizer-BioNTech Covid Vaccine for ages 12 and older early, before age of 12 years"; Bnt162b2 (Dose: 02, Lot: EW0177, Dose: Adult dose for ages 12 and over, exact strength/volume unknown-administered via injection to deltoid muscle, unknown if right or left side-caller verified same information for both first and second dose.), administration date: 05Jun2021, when the patient was 11 years old, for Covid-19 Immunization, reaction(s): "Patient adminsitered the first 2 doses of the Pfizer-BioNTech Covid Vaccine for ages 12 and older early, before age of 12 years". The following information was reported: BONE SWELLING (medically significant), PAROTID GLAND ENLARGEMENT (medically significant) all with onset 20Dec2021 12:15, outcome "not recovered" and all described as "Acute onset left mandibular and periauricular swelling, which is over the left parotid gland in the left cheek that had acute onset of swelling and pain"; IMMUNISATION (medically significant) with onset 20Dec2021 11:30, outcome "unknown", described as "booster". The patient underwent the following laboratory tests and procedures: chest x-ray: (20Dec2021) unknown results; computerised tomogram: (05Dec2021) left side plural effusion; sars-cov-2 test: (20Dec2021) negative, notes: Negative for COVID. Therapeutic measures were taken as a result of bone swelling, parotid gland enlargement. In response to event within approximately 10 minutes after onset of event: around 12:25, parent administered 25mg BENADRYL to the patient. She decided not to give him TYLENOL or ADVIL, was hoping not to since patient just got the vaccine. Outcome of event provided as persistent. She knows he has fallen asleep, but site of event still painful to touch; he's non-verbal but parent can tell just by touching the area that it was still uncomfortable; but he has no rash and no fever, but hasn't really changed. When it comes to seriousness criteria it was reported as unknown, she would say not Grade 4; but with severity of onset and the pain associated with event that if event was not better by the next day of the report she would probably take him to get a CT scan or imaging done to determine if there was evidence of a blockage. What was odd was how acutely it came on-1 minute event was not there, the next minute it was there. She would say event was definitely not life threatening, but whether it would be Grade 1, 2 or 3 she was not sure; Grade 1 would be more of irritant, she felt like that event was Grade 2 because of the pain and acute on-set-captured as medically significant conservatively relative to the parent's description. Stated that if he gets a fever she will go ahead and either start antibiotics to treat empirically like for paratitus, would be the same thing as for community acquired pneumonia, but she does not have Cefdinir at home; or take him to get a CT scan or imaging. Stated he could turn what was a little cold into a full blown ICU admission; even though he was immunocompetent if he even got mild symptoms of COVID he would be one of those kids who end up on a vent and difficult to intubate/extubate. The AEs did not require visits to emergency room nor physician's office. The patient was not hospitalized. The reporter considered the "acute onset left mandibular and periauricular swelling, which is over the left parotid gland in the left cheek that had acute onset of swelling and pain" as unknown causality, but with the proximity to timing she was suspicious event could somehow be related because that would be the first lymphatic system that would have been affected by location of the injection; would either have been axillary or neck. So her thought was because event occurred on the same side that the booster shot injection was administered that there might have been some acute inflammation in his proximal lymph nodes that could have been from that injection with the acute onset and timing relative to when he got the vaccine administered; but she honestly does not know. Further stated that if she was sitting in Pfizer's shoes doing the analysis she would say there are too many confounding factors of causality to know for sure.; Sender's Comments: Based on the available information in the case provided, the causal association between the reported events Acute onset left mandibular and periauricular swelling, parotid gland enlargement and the suspect drug BNT162B2 cannot be excluded considering drug-event temporal relationship post vaccination. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product 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.