Age: 7.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Injected limb mobility decreased, Injection site pain, Insomnia, Malaise, Nausea
Clinical narrative: tremors in both hands; Pain at injection site (Left arm); could not lift left arm; headache; hard time swallowing; trouble breathing; chest hurts; heart pounding/racing; fatigue; nausea; fever; chills / shivers; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Physician) from medical information team. The reporter is the parent. Other Case identifier(s): US-PFIZER INC-202200027161 (Pfizer), US-PFIZER INC-202200102690 (Pfizer), US-PFIZER INC-202200070803 (pfizer).  A 7 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 28Dec2021 (Lot number: FL8095, Expiration Date: 31May2022) at the age of 7 years as dose 1 (tris), single for covid-19 immunisation. Relevant medical history included: "bells palsy" (unspecified if ongoing). The patient's concomitant medications were not reported.  The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 28Dec2021, outcome "recovered" (29Dec2021), described as "Pain at injection site (Left arm)"; INJECTED LIMB MOBILITY DECREASED (non-serious) with onset 28Dec2021, outcome "recovered" (29Dec2021), described as "could not lift left arm"; HEADACHE (non-serious) with onset 28Dec2021, outcome "not recovered", described as "headache"; DYSPHAGIA (non-serious) with onset 28Dec2021, outcome "recovered" (29Dec2021), described as "hard time swallowing"; DYSPNOEA (non-serious) with onset 28Dec2021, outcome "recovered" (29Dec2021), described as "trouble breathing"; CHEST PAIN (non-serious) with onset 28Dec2021, outcome "not recovered", described as "chest hurts"; HEART RATE INCREASED (non-serious) with onset 28Dec2021, outcome "not recovered", described as "heart pounding/racing"; FATIGUE (non-serious) with onset 28Dec2021, outcome "unknown", described as "fatigue"; NAUSEA (non-serious) with onset 28Dec2021, outcome "not recovered", described as "nausea"; PYREXIA (non-serious) with onset 28Dec2021, outcome "recovered" (29Dec2021), described as "fever"; CHILLS (non-serious) with onset 28Dec2021, outcome "unknown", described as "chills / shivers"; TREMOR (non-serious) with onset 04Jan2022, outcome "recovered" (05Jan2022), described as "tremors in both hands". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of vaccination site pain, injected limb mobility decreased, headache, dysphagia, dyspnoea, chest pain, heart rate increased, fatigue, nausea, pyrexia, chills, tremor.  Additional information: The reporter confirmed that chest pain started the same day within 1 hour of vaccination, along with the difficulty breathing.  He is concern that the "chills have persisted" and "the nausea is persisting" noting "now on day 10 and he felt like he was going to throw up yesterday" and that "he was a 100% perfectly healthy child up until the 28th". He reports "the chest hurting kind of persists as well, not as much." Caller noted they "didn't go to the hospital because he was just sitting watching TV, saw that he was having difficulty breathing, but he was breathing so he wasn't going into anaphylactic shock. Of course, the patient do have an Epipen at home, but there was no need for it". Caller is concerned about the shaking/tremoring hands "started a week after he got the vaccine" stating "on Tuesday he had the shivers and he put his hands out and his hands were shaking like a 90y/o man trying to grab a glass of water, and he said his heart was racing". Patient was seen by his pediatrician on Wednesday 05Jan2022, and "he told them he had the tremors in both of his hands" and the doctor "said everything looks fine" but "he was in there, and he was sick. He was fatigued, tired, just overall bad. The patient was kept home from school, he couldn't go to school on Wednesday. He went to school on Thursday and started feeling nauseous after school, like he was going to throw up. Today he went to school and that's kind of where they are at". The reporter wanted to know what is considered an adverse reaction that may be considered more serious than an adverse reaction like he has shivers in his hands. Stated that his son is 7 years old and had on 28Dec at 3pm his first shot and afterwards had symptoms of pain at the injection site, whole arm hurt and he could not lift it. Stated that shortly after, he had a headache, had a hard time swallowing, trouble breathing, chest hurts, heart pounding within an hour of the vaccination. Is for Covid (7 year old) Stated that he had fatigue, nausea, fever, chills which has been persisting for a week. Stated that since then he has either chills or nausea that has lasted the last five days. Stated that again on 01Jan that his chest was hurting and he had shivers (tremors in both hands). Stated that the headaches persisted on 04Jan. Stated that on 05Jan that he saw the pediatrician and had no tremors. Stated that he was checked out and the pediatrician said he was okay at that report. Stated that last night he felt nauseous. Wanted to know of these reactions are these considered adverse reactions. Reporter stated that yesterday nausea was bad other days feels like tummy hurts which is intermittent and varies. Later clarified that the tremors (shivers) in both hands started on 04Jan. Treatment included: Stated that he put ice on the injection site and left arm. Saw pediatrician on 05Jan for chest hurting and prescribed no treatment only to monitor. Stated he rested for the fatigue. Caller states his son had a lot of different adverse reactions where some may be considered serious and some may be considered mild. Caller states his son did have a fast heart beat, and the first day his son said he had a little trouble breathing within 1 hour of getting the vaccine but subsided. Caller stated he had an EpiPen in hand but did not use it. Caller states his son described feeling his heart racing, having the shivers and his hand was shaking where he had trouble grabbing a glass of water. Caller states the tremors subsided after a while. Caller states to him, tremors and a fast heart beat is considered a serious AE for him. Caller states his son was 100% healthy on the 27th, and now the fast heart beat is persisting at times. Caller states he took his son to the doctor, the pediatrician was dismissive and directed him to Pfizer. The reporter wanted to know the location of the headache. He had chest pain he is seeing paediatric cardiologist today to see if this is myocarditis or pericarditis. Physician stated, "could see a bells palsy on the left, Left facial bells palsy and was trying to determine if that was before or after the vaccine but that is reportable to theirs (further clarification unknown hence not captured in tab)." Treatment: Physician stated, "He took Benadryl and Tylenol" (as reported). The reporter wanted to confirm the recommended dosing interval for the second dose is 3 weeks, as that deadline is approaching and he needs to decide whether to get his child the second dose.  Follow-up attempts are completed. No further information is expected.