Age: 4.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic reaction, Blood test, Gait disturbance, Muscle twitching, Pain in extremity
Clinical narrative: he was having anaphylaxis reaction; eyes began twitching; throat clearing; having extreme pain in both of his legs; difficulty walking; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 4-year-old male patient received BNT162b2 (BNT162B2), on 04Aug2022 as dose 1, single (Batch/Lot number: unknown) at the age of 4 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Peanuts" (unspecified if ongoing), notes: known allergies: Peanuts; "covid positive in January", start date: Jan2022 (unspecified if ongoing), notes: covid positive in January; "pneumonia" (unspecified if ongoing), notes: pneumonia twice within a year before surgery; "surgery" (unspecified if ongoing), notes: pneumonia twice within a year before surgery. Concomitant medication(s) included: SINGULAIR; SYMBICORT; ALBUTEROL [SALBUTAMOL]; ZYRTEC [CETIRIZINE HYDROCHLORIDE]. Past drug history included: Cefdinir, reaction(s): "Allergy". The following information was reported: GAIT DISTURBANCE (non-serious) with onset 04Aug2022, outcome "not recovered", described as "difficulty walking"; MUSCLE TWITCHING (non-serious) with onset 04Aug2022, outcome "not recovered", described as "eyes began twitching"; PAIN IN EXTREMITY (non-serious) with onset 04Aug2022, outcome "not recovered", described as "having extreme pain in both of his legs"; ANAPHYLACTIC REACTION (medically significant) with onset 04Aug2022, outcome "not recovered", described as "he was having anaphylaxis reaction"; THROAT CLEARING (non-serious) with onset 04Aug2022, outcome "recovered" (2022). The events "he was having anaphylaxis reaction", "eyes began twitching", "throat clearing", "having extreme pain in both of his legs" and "difficulty walking" required physician office visit. The patient underwent the following laboratory tests and procedures: Blood test: (unspecified date) Unknown, notes: He's had bloodwork done and we're waiting for the results; SARS-CoV-2 test: (Jan2022) Positive, notes: covid positive in January. Therapeutic measures were not taken as a result of anaphylactic reaction, muscle twitching, throat clearing. Therapeutic measures were taken as a result of pain in extremity, gait disturbance.  Clinical course: Within 15 minutes after receiving the Covid-19 vaccine my son started making a strange sound with his throat. He was repeatedly making a throat clearing sound. Adverse event making a throat clearing sound. I immediately called his pediatrician and asked if this was normal and the woman said yes. He does have a severe peanut allergy and I was concerned that he was having an anaphylaxis reaction to the vaccine. This throat clearing went on for about 2 weeks and he did it constantly. When the throat clicking stopped, both of his eyes began twitching excessively. The doctor said they are tics and have yet to disappear. He also began having extreme pain in both of his legs. He has difficulty walking at times. The pain lasts all day and night. I've tried motrin and Tylenol, but they have zero effect on the pain. I've taken him to his pediatrician, a neurologist, an ophthalmologist, optometrist and an orthopedic. He's scheduled to see a rheumatologist next week. He's had bloodwork done and we're waiting for the results. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had not been tested for COVID-19 Since the vaccination.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.