Age: 20.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Chest X-ray normal, Computerised tomogram head, Electrocardiogram normal, Injection site pain
Clinical narrative: Red area on both arms and chest that went away; C-Reactive Protein, elevated to 10.1; Elevated platelet count, watching for thrombocytopenia, highest 559; left arm was sore and cramping; he could not move his arms; left arm was sore and cramping; Elevated white blood cell count 18, 000; low grade fever; This is a spontaneous report from a contactable nurse (patient's mother). A 20-year-old male patient received the 2nd dose bnt162b2 (Pfizer-BioNTech COVID-19 vaccine, lot number: FF2589) via an unspecified route of administration in the left arm on 15Oct2021 at 15:30 at age of 20 years old as single dose for COVID-19 immunization. Medical history was unknown. Concomitant medications were none. The patient previously received the 1st dose of BNT162B2 (lot number: FF2587) via an unspecified route of administration in the left arm on 21Sep2021 at 3:30PM at age of 20 years old for Covid-19 immunization; DTAP on 20Jul2021 at age of 12 years old and 5 days later, the patient went into respiratory distress and went into a coma with viral meningitis, and encephalitis. The patient received his second dose of the Pfizer vaccine on 15Oct2021 and had severe adverse reactions. The patient had no issues at first. At first his left arm was sore and cramping and then within 10 days, extending to both arms with severe pain and loss of use, both arms around his biceps to his deltoid, had severe pain and cramping, and he went to the emergency room. The patient had a chest x-ray, EKG, heat cat scan, and all the tests were normal. He did have an elevated white blood cell count of 18,000 on 26Oct2021 at 1 am. It had gone down to 10,000. The patient had low grade fever on 25Oct2021 at 23:00, and he could not move his arms. The patient was not crying in pain, but still cannot use his arms. The patient experienced Elevated platelet count, watching for thrombocytopenia, highest 559 on 26Oct2021 at 04:41. The reported stated it started at 441 on 26Oct2021, and then went up to 559, and the seriousness could be life-threatening. The patient experienced C-Reactive Protein, elevated to 10.1 after second vaccine on 29Oct2021 at 22:00. The patient experienced red area on arms and chest on 29Oct2021 at around 10 pm, that went away. The patient had other blood tests, and they were all normal. Outcome of the event "Elevated white blood cell count 18, 000", "left arm was sore and cramping", "he could not move his arms" was recovering, of the event "Elevated platelet count, watching for thrombocytopenia, highest 559" was not recovered, of the event "Red area on both arms and chest that went away" and "low grade fever" was recovered on 01Nov2021, of the event "C-Reactive Protein, elevated to 10.1" was unknown. AE(s) require a visit to Emergency Room twice, and visit to Physician Office three times. Seriousness for event "Left arm was sore and cramping" was Disabling. Seriousness for event "Elevated white blood cell count 18, 000" was Life threatening. Seriousness for event "Low grade fever" was not serious. Seriousness for event "Elevated platelet count, watching for thrombocytopenia, highest 559" was Medically significant and life-threatening. Seriousness for event "Red area on both arms and chest that went away" was Medically significant. Event relatedness was reported as related for all events.; Sender's Comments: Based on the information available and temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events . 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.