Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate abnormal, Heart rate increased, Hemiparesis, Hypoaesthesia
Clinical narrative: migraines with auras; Chest tightness; swollen lymph nodes in neck/underarms; severe headaches; mouth pain; ear pain; dizziness; shortness of breath; increased heart rate; increased blood pressure; 30lb weight loss; blurred vision; dry eyes/mouth; dry eyes/mouth; severe neck stiffness; laryngospasm; stomach upset; numbness/tingling on right side of face; numbness/tingling on right side of face; right eye/face droop; right eye/face droop; difficulty speaking; neck and chest pain; neck and chest pain; weakness in right side of body; brain fog; temperature intolerance; sleep disturbances; inconsistent heart rate; inconsistent blood pressure; bulging veins in leg; tremors; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 38-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Dec2021 as dose 3 (booster), single (Lot number: FJ8762) at the age of 39 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "anemia" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "dry eyes" (unspecified if ongoing); "sleep apnea" (unspecified if ongoing); "gerd" (unspecified if ongoing); "arthritis" (unspecified if ongoing); "fibromyalgia" (unspecified if ongoing); "migraines" (unspecified if ongoing). Concomitant medication(s) included: HYDROCHLOROTHIAZIDE; MONTELUKAST; ADVAIR; NIFEDIPIN. Past drug history included: Amoxicillin, reaction(s): "Known allergies: Amoxicillin". Other vaccine was also taken on 13Dec2021. Vaccination history included: BNT162b2 (Dose 1, Single, Batch/Lot No: EW0164, Location of injection: Arm Left), administration date: 30Apr2021, for COVID-19 immunisation; BNT162b2 (Dose 2, Single, Batch/Lot No: EW0186, Location of injection: Arm Left), administration date: 21May2021, for COVID-19 immunisation, reaction(s): "loss of sight and inability to speak.", "loss of sight and inability to speak.". The following information was reported: VISION BLURRED (hospitalization) with onset Apr2022, outcome "not recovered", described as "blurred vision"; BRAIN FOG (hospitalization) with onset Apr2022, outcome "not recovered"; VARICOSE VEIN (hospitalization) with onset Apr2022, outcome "not recovered", described as "bulging veins in leg"; SPEECH DISORDER (hospitalization) with onset Apr2022, outcome "not recovered", described as "difficulty speaking"; DRY EYE (hospitalization), DRY MOUTH (hospitalization) all with onset Apr2022, outcome "not recovered" and all described as "dry eyes/mouth"; BLOOD PRESSURE ABNORMAL (hospitalization) with onset Apr2022, outcome "not recovered", described as "inconsistent blood pressure"; HEART RATE ABNORMAL (hospitalization) with onset Apr2022, outcome "not recovered", described as "inconsistent heart rate"; LARYNGOSPASM (hospitalization) with onset Apr2022, outcome "not recovered"; NECK PAIN (hospitalization), CHEST PAIN (hospitalization) all with onset Apr2022, outcome "not recovered" and all described as "neck and chest pain"; HYPOAESTHESIA (hospitalization), PARAESTHESIA (hospitalization) all with onset Apr2022, outcome "not recovered" and all described as "numbness/tingling on right side of face"; FACIAL PARALYSIS (hospitalization), EYELID PTOSIS (hospitalization) all with onset Apr2022, outcome "not recovered" and all described as "right eye/face droop"; MUSCULOSKELETAL STIFFNESS (hospitalization) with onset Apr2022, outcome "not recovered", described as "severe neck stiffness"; SLEEP DISORDER (hospitalization) with onset Apr2022, outcome "not recovered", described as "sleep disturbances"; ABDOMINAL DISCOMFORT (hospitalization) with onset Apr2022, outcome "not recovered", described as "stomach upset"; TEMPERATURE INTOLERANCE (hospitalization) with onset Apr2022, outcome "not recovered"; TREMOR (hospitalization) with onset Apr2022, outcome "not recovered", described as "tremors"; HEMIPARESIS (hospitalization) with onset Apr2022, outcome "not recovered", described as "weakness in right side of body"; WEIGHT DECREASED (hospitalization) with onset Sep2022, outcome "not recovered", described as "30lb weight loss"; DIZZINESS (hospitalization) with onset Sep2022, outcome "not recovered"; EAR PAIN (hospitalization) with onset Sep2022, outcome "not recovered"; BLOOD PRESSURE INCREASED (hospitalization) with onset Sep2022, outcome "not recovered", described as "increased blood pressure"; HEART RATE INCREASED (hospitalization) with onset Sep2022, outcome "not recovered", described as "increased heart rate"; ORAL PAIN (hospitalization) with onset Sep2022, outcome "not recovered", described as "mouth pain"; HEADACHE (hospitalization) with onset Sep2022, outcome "not recovered", described as "severe headaches"; DYSPNOEA (hospitalization) with onset Sep2022, outcome "not recovered", described as "shortness of breath"; LYMPHADENOPATHY (hospitalization) with onset Sep2022, outcome "not recovered", described as "swollen lymph nodes in neck/underarms"; CHEST DISCOMFORT (hospitalization) with onset Mar2023, outcome "not recovered", described as "Chest tightness"; MIGRAINE WITH AURA (hospitalization) with onset Mar2023, outcome "not recovered", described as "migraines with auras". The patient was hospitalized for vision blurred, dry eye, dry mouth, musculoskeletal stiffness, laryngospasm, abdominal discomfort, hypoaesthesia, paraesthesia, facial paralysis, eyelid ptosis, speech disorder, neck pain, chest pain, hemiparesis, brain fog, temperature intolerance, sleep disorder, heart rate abnormal, blood pressure abnormal, varicose vein, tremor, lymphadenopathy, headache, oral pain, ear pain, dizziness, dyspnoea, heart rate increased, blood pressure increased, weight decreased, migraine with aura, chest discomfort (hospitalization duration: 10 day(s)). The events "blurred vision", "dry eyes/mouth", "severe neck stiffness", "laryngospasm", "stomach upset", "numbness/tingling on right side of face", "right eye/face droop", "difficulty speaking", "neck and chest pain", "weakness in right side of body", "brain fog", "temperature intolerance", "sleep disturbances", "inconsistent heart rate", "inconsistent blood pressure", "bulging veins in leg", "tremors", "swollen lymph nodes in neck/underarms", "severe headaches", "mouth pain", "ear pain", "dizziness", "shortness of breath", "increased heart rate", "increased blood pressure", "30lb weight loss", "migraines with auras" and "chest tightness" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: Blood pressure measurement: (Apr2022) inconsistent; (Sep2022) increased; Heart rate: (Apr2022) inconsistent; (Sep2022) increased; Weight: (Sep2022) 30 loss, notes: 30lb weight loss. Therapeutic measures were taken as a result of vision blurred, dry eye, dry mouth, musculoskeletal stiffness, laryngospasm, abdominal discomfort, hypoaesthesia, paraesthesia, facial paralysis, eyelid ptosis, speech disorder, neck pain, chest pain, hemiparesis, brain fog, temperature intolerance, sleep disorder, heart rate abnormal, blood pressure abnormal, varicose vein, tremor, lymphadenopathy, headache, oral pain, ear pain, dizziness, dyspnoea, heart rate increased, blood pressure increased, weight decreased, migraine with aura, chest discomfort. Patient also took seizure, BP, migraine meds.; Sender's Comments: As there is limited information in the case provided, the causal association between the Reported events vision blurred, dry eye, dry mouth, musculoskeletal stiffness, laryngospasm, abdominal discomfort, hypoaesthesia, paraesthesia, facial paralysis, eyelid ptosis, speech disorder, neck pain, chest pain, hemiparesis, brain fog, temperature intolerance, sleep disorder, heart rate abnormal, blood pressure abnormal, varicose vein, tremor, lymphadenopathy, headache, oral pain, ear pain, dizziness, dyspnoea, heart rate increased, blood pressure increased, weight decreased, migraine with aura, chest discomfort and the suspect drug cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer drug 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.,Linked Report(s) : US-PFIZER INC-202300251628 same patient, same products, different events (dose 2);US-PFIZER INC-202300252275 same patient, same products, different events;