Age: 2.0
Sex: M
Vaccine: COVID19
Symptoms: Lacrimation increased, Periorbital swelling, Regurgitation
Clinical narrative: fatigue; pink eye; watery eyes/eye was very watery; his reflux was aggravated; had regurgitation in the back of his throat; swelling around eye/right eye that is watery and puffy; This is a spontaneous report received from contactable reporter(s) (Nurse) from medical information team. The reporter is the parent.  A 2-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 06Mar2023 at 09:30 as dose 3 (maroon cap), 0.2 ml single (Lot number: GK1667) at the age of 2 years, in right thigh for covid-19 immunisation. The patient's relevant medical history included: "reflux infant" so has a history of reflux but has resolved" (unspecified if ongoing), notes: that her son is a "reflux infant" so has a history of reflux but has resolved; "after being sick", start date: 24Feb2023 (unspecified if ongoing), notes: had tested positive for parainfluenza type 3 on 24Feb2023 after being sick; "parainfluenza type 3", start date: 24Feb2023 (unspecified if ongoing), notes: had tested positive for parainfluenza type 3 on 24Feb2023 after being sick. Concomitant medication(s) included: ALBUTEROL SULFATE taken for parainfluenzae virus infection, start date: 28Feb2023. Vaccination history included: BNT162b2 (2nd dose: Pfizer COVID vaccine, maroon, 6 months to 4 years old, NDC number: Unknown, Lot number: FT9142, Expiration date: Unknown, Dose, route, anatomical location: 0.2mL, given in thigh muscle, Time given: 8AM), administration date: 07Oct2022, when the patient was 1-year-old, for COVID-19 immunization, reaction(s): "fatigue", "his reflux was aggravated", "had regurgitation in the back of his throat"; BNT162b2 (1st dose: Pfizer COVID vaccine, NDC number: Unknown, Lot number: FT9142, Expiration date: 31Dec2022, Dose, route, anatomical location: In thigh, doesn't remember which thigh, intramuscular, thinks 5mcg, whatever the dose is for 6 months to 4 years. Time given: In afternoon), administration date: 16Sep2022, when the patient was 1-year-old, for COVID-19 immunization, reaction(s): "fatigue", "had regurgitation in the back of his throat", "his reflux was aggravated". The following information was reported: REGURGITATION (non-serious) with onset 06Mar2023, outcome "not recovered", described as "had regurgitation in the back of his throat"; GASTROOESOPHAGEAL REFLUX DISEASE (non-serious) with onset 06Mar2023, outcome "not recovered", described as "his reflux was aggravated"; PERIORBITAL SWELLING (non-serious) with onset 06Mar2023, outcome "not recovered", described as "swelling around eye/right eye that is watery and puffy"; LACRIMATION INCREASED (non-serious) with onset 07Mar2023, outcome "not recovered", described as "watery eyes/eye was very watery"; FATIGUE (non-serious), outcome "unknown"; CONJUNCTIVITIS (non-serious), outcome "unknown", described as "pink eye". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Upon further discussion, mother of patient reported that her son was a "reflux infant" so has a history of reflux but had resolved. She reported that every time he got the vaccine (has received 3 doses), it aggravated his reflux or it started acting up again. On Monday, 06Mar2023, he received his Pfizer Covid 19 vaccine bivalent booster for 6 month to 4 years old, and she noticed that night his reflux was aggravated and had regurgitation in the back of his throat that night and has been occurring intermittently since then. This same thing happened with his first two doses in his primary series. This recent bivalent vaccine booster is his third COVID vaccine dose and he is now fully vaccinated. The reporter stated that she did a (website name) search with the following search terms: "swollen eye after COVID booster" and found reports of periorbital swelling in adults. Patient received 3rd dose 0.2mL, given in right thigh muscle. The patient, who just received the Pfizer bivalent booster. Patient got boosted on Monday for patient's 3rd dose which was the completion of initial series. Yesterday reporter started noticing swelling around patient's eye, eye was very watery, and fairly swollen. Did quick search because didn't think this was related to the COVID shot, but then found stuff so reporter wanted to reach out because reporter was wondering is this a known common side effect? Did patient need to go to doctor? reporter was also patient's mom. Patient height: Pretty tall, thinks like 35 inches. Patient weight: Thinks 27.5 pounds. Swelling around eye: Start date of adverse event: Thinks noticed later in the day Monday night, 06Mar2023, within the first 12 hours of getting boosted, then thought today may be related to the vaccine since no other concerns, healthy otherwise reporter thinks. Just has swelling around the right eye. Seriousness criteria: Unknown, did not think serious, just noticed, thought does patient have pink eye or was this related to getting boosted, but there was no redness at all. Eye was very watery: Start date of adverse event: Just the right eye that was watery and puffy, eye was very watery started yesterday, 07Mar2023. Seriousness criteria: Unknown Bivalent booster 6 months to 4 year old dose: Clarified and confirmed this was patient's 3rd dose total and the 3rd dose was the Pfizer bivalent booster 6 months to 4 year old dose, therefore bivalent booster 6 months to 4 year old dose placed in formal field. Patient got the 2 initial doses and then this was 3rd dose, so now patient is full vaxxed. First 2 doses were the Pfizer COVID vaccine. Patient does always get reflux with the vaccine as well, reflux is waking patient up at night. Would say reflux is fairly mild but patient has had reflux with every vaccine, with the first 2 doses had the reflux and then the normal fatigue. With this 3rd dose, had reflux again and the swollen eye. Test results: Patient had blood work the same day right before, no additional information provided. Medical conditions: Thinks patient has been on and off sick for the past 6 months like every other child in the country. Concomitant products: Tried albuterol sulfate HFA inhalation aerosol, but thinks that was 10 days prior, that was for a prior illness, clarified patient had parainfluenza type 3. Albuterol sulfate HFA inhalation aerosol: Manufacturer: Prasco, NDC number, lot number, expiration date: Not provided, non-Pfizer product. Patient just trialed product once or twice but product didn't help. Indication: Parainfluenza type 3. Therapy dates: Was around 28Feb2023, had tested positive for parainfluenza type 3 on 24Feb2023 after being sick, on 18Feb2023 had viral symptoms which started the following Friday, so had patient swabbed and then tested positive for parainfluenza type 3 on 24Feb2023. Strength: 90mcg per actuation, which reporter thinks means per puff Seattle Children's gave caller 4 or 5 pages of written information of common side effects. Causality: swelling around eye: reporter was now starting to wonder if yes, because in the absence of anything else. Causality: eye was very watery: Reporter was now starting to wonder if yes, because in the absence of anything else.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300102461 Same reporter, same patient, different shot/event;