Sex: M
Vaccine: COVID19
Symptoms: Electrocardiogram ambulatory, Epstein-Barr virus antibody, Epstein-Barr virus test, Haematocrit, Haemoglobin
Clinical narrative: generalized body aches; upper abdominal pain; headache; rigors; fever; chest pain; dyspnea; myalgia; tachycardia; mild hypertension; leukocytosis;   This is a non-interventional study report (Post Authorization Safety Study) received from a contactable reporter(s) (Other HCP).  A 22-year-old male patient participated in the above study and received his first dose of BNT162b2 (BNT162B2), on 04Aug2021 as dose 1, single intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Anxiety" (ongoing); "Gastroesophageal reflux disease" (ongoing); "Depression" (ongoing); "COVID-19 infection", start date: Oct2020 (unspecified if ongoing); "Fatigue", start date: Oct2020 (ongoing); "Heart palpitations", start date: Oct2020 (ongoing); "Antinuclear antibodies screen positive" (unspecified if ongoing). Concomitant medications included: PROVENTIL [SALBUTAMOL SULFATE] resp inhalation (ongoing); FIORICET oral (ongoing); VITAMIN D [COLECALCIFEROL] oral (ongoing); KLONOPIN oral (ongoing); EPINEPHRINE (ongoing); FLONASE [FLUTICASONE PROPIONATE] resp inhalation (ongoing); NAPROSYN E oral (ongoing); PRILOSEC [OMEPRAZOLE] oral (ongoing). Past drug history included: Levaquin, reaction(s): "Allergies-itching", notes: from unknown date and ongoing; Peppermint oil, reaction(s): "Allergies-itching", notes: from unknown date and ongoing; Rocephin, reaction(s): "Allergies-nausea and vomiting", notes: from unknown date and ongoing; Rocephin, reaction(s): "Allergies-nausea and vomiting", notes: from unknown date and ongoing. The following information was reported: LEUKOCYTOSIS (hospitalization) with onset 08Aug2022 (as reported); HYPERTENSION (hospitalization) with onset 08Aug2022 (as reported), described as "mild hypertension"; TACHYCARDIA (hospitalization) with onset 08Aug2022 (as reported); PYREXIA (hospitalization) with unknown onset, described as "fever"; CHEST PAIN (hospitalization) with unknown onset; PAIN (hospitalization) with unknown onset, described as "generalized body aches"; ABDOMINAL PAIN UPPER (hospitalization) with unknown onset, described as "upper abdominal pain"; HEADACHE (hospitalization) with unknown onset; CHILLS (hospitalization) with unknown onset, described as "rigors"; DYSPNOEA (hospitalization) with unknown onset, described as "dyspnea"; MYALGIA (hospitalization) with unknown onset. The patient was hospitalized for pyrexia, chest pain, tachycardia, pain, abdominal pain upper, headache, chills, hypertension, leukocytosis, dyspnoea, myalgia (discharge date: 09Aug2022 (as reported)). Clinical course: On 08Aug2021, the patient presented to emergency department (ED) with myalgias, fever/chills, chest pain, generalized body aches, upper abdominal pain, headache, and dyspnea in the setting of recent COVID-19 immunization on 04Aug2021. He moved to this area 1 week ago and had a long car ride with the move. He was initially seen in the ED on 07Aug2021 and diagnosed with viral illness. However, the patient had persistent fevers and returned to the ED on 08Aug2021. He was most bothered by rigors. The patient stated that shortly after receiving the Pfizer COVID-19 vaccine on 04Aug2021, he developed headache and some myalgias. He stated that shortly afterwards he noticed dyspnea and chest pain. The patient had COVID-19 in Oct2020, but he was not hospitalized. He had had "heart palpitations" and fatigue since getting COVID. The patient stated that the fatigue had never fully resolved after getting COVID. Of note, the patient's care review demonstrated multiple office and urgent care visits for numerous complaints including abdominal pain, constipation, muscular twitching, headache, sinusitis, chest pain and palpitations. Brain Magnetic resonance imaging/magnetic resonance angiography (MRI/MRA) was negative. Stress test in May2021 was negative. 14 day cardiac monitoring in May2021 revealed "heart rates varied between 41 and 177 beats per minute (bpm) with an average of 79 bpm. The predominant rhythm was Normal sinus rhythm (NSR) and Ectopic Atrial rhythm (EAR). Triggered events corresponded to sinus arrhythmias, sinus tachycardia, and ectopic atrial rhythms. In Apr2021, Erythrocyte sedimentation rate (ESR) was 19 and C-reactive protein (CRP) was 9. On an unknown date, the patient had a prior antinuclear antibodies (ANA) screen positive. Reflex appeared negative. Epstein-Barr virus Immunoglobulin G (EBV IgG) was elevated but Immunoglobulin M (IgM) was negative. In Apr2021, lower extremity (LE) ultrasound (u/s) was negative. In Mar2021, head Computed tomography (CT) was negative. Also in Mar2021, Holter monitor with heart rates (HRs) 42-154 (sinus rhythm). Multiple troponin checked were negative. Per cardiology note from Apr2021, transthoracic echocardiogram (TTE) with normal left ventricular (LV) function. Holter monitoring with sinus tachycardia. Per physical examination, the patient was in no acute distress, but was highly anxious. Vital signs as noted below. The patient was tachycardic, but with a regular heart rhythm; no MGR (murmurs, gallops, or rubs). No accessory muscle use, rales, or wheezing noted. No abdominal masses, tenderness, or rebound noted. Electrocardiogram (ECG) showed sinus tachycardia with heart rate in the 130s, with nonspecific ST-T wave changed. While in the emergency department (ED), the patient also felt palpitations and was unsteady while walking to the bathroom. The patient was admitted for monitoring and observation. Medications given in the ED included enoxaparin sodium (LOVENOX) 40 mg subcutaneously, ketorolac tromethamine (TORADOL) 15 milligrams (mg) intravenous (IV), acetaminophen (TYLENOL) 1000 mg, and a 500 cubic centimeters ( cc) normal saline bolus. Laboratory and diagnostic tests as noted below. Computed tomography angiogram of chest negative for pulmonary embolism, no abnormalities on chest x-ray, and troponins negative. Blood cultures sent, but results pending at discharge. Vital signs stable (blood pressure elevated on admission but improved overnight) and no significant events were noted on telemetry). The cardiology team was consulted. They recommended echocardiogram and cardiac MRI. Echocardiogram performed (results  below), but patient declined cardiac MRI due to concern regarding price. Cardiology team recommended continuing non-steroidal anti-inflammatory drug (NSAID) for possible costochondritis causing chest pain, with office follow-up in 2 weeks. The participant was hemodynamically stable at the time of discharge on 09Aug2022. Discharge recommendations included continuing with COVID vaccination and obtain 2nd vaccine when due. On 08Aug2021 at 14:50: Pulse 137, oxygen saturation (SpO2) 100% on Room air. On 08Aug2021 at 14:54: blood pressure (bp) 162/93, temperature 102 degrees Fahrenheit (F) (oral), pulse 127, respirations 20, SpO2 99%. On 08Aug2021 at 17:01: temperature 98.7 degrees F (oral), respirations 17. On 08Aug2021 17:30 - bp 137/63, pulse 113, respirations 17, SpO2 99%. On 08Aug2021 0347 CBC -WBC 10.78 x 10.3/uL (reference ranges not reported for any labs), Hgb 14.6 g/dL, Hct 42.9%, Platelets 199 x 10^6/uL. On 08Aug2021 04:00 Troponin I -0.01. On 08Aug2021 16:12 Troponin I-0.01 ng/ml, Sed Rate 19 mm/Hr, C-Reactive protein 9.3 mg/d/L, COVID-19 (SARS-COV-2) and influenza (Liat Rapid)-SARS CoV2 not detected, Influenza A and Influenza B not detected. On 08Aug2021 16:12 WBC 12.17 x 10^3/uL, Hgb 15.2 g/dL, Hct 44.9%, Platelets 220 x10^ 3uL. On 08Aug2021 23:24 Respiratory Pathogen PaneL PCR-without COVID-19- nothing detected. On 08Aug2021 06:15 X-ray (XR) Chest Anterior Posterior (AP) Portable -no acute pulmonary process. On 08Aug2021 16:39 Computed tomography (CT) Angio Chest (PE study) -negative for pulmonary embolism. On 09Aug2021 time unknown - bp 121/72, pulse 81, temperature 98.1 degrees F (oral), respirations 16, SpO2 100%. On 09Aug2021 12:32 Echocardiogram with Doppler waveform- no significant valvular abnormalities, no pulmonary hypertension, and no pericardial effusion. Physician assessment: "Fever likely SIRS response 2/2 post-vaccine reaction vs. Active infection," "Sinus tach likely 2/2 infection," and "Leukocytosis likely 2/2 reactive process vs. infection" Diagnosis/clinical impression: Symptomatic immune response to COVID-19 vaccine, SIRS (Systemic Inflammatory Response Syndrome) after COVID-19 vaccine, sepsis ruled out, and atypical chest pain. The action taken in response to the events for BNT162b2 was not applicable. Outcome for the event leukocytosis was recovering, for events mild hypertension, tachycardia, fever and upper abdominal pain was recovered on 09Aug2022 (as reported), for events chest pain, generalized body aches, headache, rigors, dyspnea and myalgia was recovered on unknown date.  The reporter considered "fever", "chest pain", "tachycardia", "generalized body aches", "upper abdominal pain", "headache", "rigors", "mild hypertension", "leukocytosis", "dyspnea" and "myalgia" related to BNT162b2, but unrelated to concomitant drugs.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine cannot be excluded for the reported events of fever, chest pain, tachycardia, generalized body aches, upper abdominal pain, headache, rigors, mild hypertension, leukocytosis, dyspnea and myalgia. 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.