Report #2830526

Overview

Sex

Female

Age

40 yrs

State

TX

Recovered

Not recovered

Vaccinated

Jan 5, 2021

Onset

Jan 1, 2021

Days to onset

—

Hospital days

—

Symptoms (33)

Symptom narrative

a major episode; concentration issues; fatigue; forgetfulness; speech issues; seizure activity/witnessed syncopal episode with convulsive spells; loss of consciousness; dizzy/lightheaded/light headedness; nausea; vomiting; witnessed syncopal episode with convulsive spells/problem with concentration fainting; Allergic reaction/anaphylaxis; tachypneic; rigors; electrolyte abnormality/mild hypokalemia; dehydration; headache; tremors; The initial case was missing the following minimum criteria: Unspecified product. Upon receipt of follow-up information on 05Mar2025, this case now contains all required information to be considered valid. This is a spontaneous report received from a Physician, Program ID. A 40-year-old female patient received BNT162b2 (BNT162B2), on 05Jan2021 (reported as am) as dose 1, single (Lot number: EL0140) at the age of 40 years intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Achilles tendinitis" (unspecified if ongoing); "Contracture of left Achilles tendon", start date: 2017 (unspecified if ongoing); "Depression" (unspecified if ongoing); "Fibromyalgia" (unspecified if ongoing); "Gastrocnemius equinus" (unspecified if ongoing); "GERD (gastroesophageal reflux disease)" (unspecified if ongoing); "Morbid obesity" (unspecified if ongoing), notes: with body mass index (BMI) of 40.0 or higher (HCC); "Peripheral sensory neuropathy" (unspecified if ongoing); "Rheumatoid arthritis (714.0)" (unspecified if ongoing); "Seasonal allergies" (unspecified if ongoing); "Cholecystectomy" (unspecified if ongoing); "Carpal tunnel release" (unspecified if ongoing); "Foot ganglion excision" (unspecified if ongoing); "Knee Arthroscopy" (unspecified if ongoing), notes: Literality: Bilateral, Literality: Right; "Thyroidectomy, partial" (unspecified if ongoing), notes: Literality: Right; "Tonsillectomy" (unspecified if ongoing); "Wisdom tooth extraction" (unspecified if ongoing); "Tobacco use" (unspecified if ongoing); "Never smoker" (unspecified if ongoing), notes: Smokeless tobacco: Never used, Substance use topics; "Alcohol use: Yes" (unspecified if ongoing), notes: Frequency: Monthly or less, Drinks per session: 1 or 2; "arthritis" (unspecified if ongoing); "low vitamin D levels" (unspecified if ongoing). No Known Drug Allergies reported for patient. Never binge frequency. Never drug use. The patient's family history includes hypertension, lupus, clotting disorder, heart disease, mitral valve prolapse, and type II diabetes in the father; hypertension, osteoporosis, heart disease, and mitral valve prolapse in the mother; hypertension and type II diabetes in the brother; breast cancer, hypertension, and type II diabetes in the maternal aunt; breast cancer in a cousin; and hypertension and type II diabetes in the maternal uncle. Concomitant medication(s) included: ZOLOFT taken for depression; PROTONIX [OMEPRAZOLE] taken for gastrooesophageal reflux disease; MOBIC taken for arthritis; NORVASC taken for hypertension; VITAMIN D2 taken for vitamin d deficiency. The following information was reported: ANAPHYLACTIC REACTION (disability) with onset 05Jan2021, outcome "recovered with sequelae", described as "Allergic reaction/anaphylaxis"; DEHYDRATION (disability) with onset 05Jan2021, outcome "recovered with sequelae"; DIZZINESS (disability) with onset 05Jan2021, outcome "recovered with sequelae", described as "dizzy/lightheaded/light headedness"; HYPOKALAEMIA (disability) with onset 05Jan2021, outcome "recovered with sequelae", described as "electrolyte abnormality/mild hypokalemia"; LOSS OF CONSCIOUSNESS (disability, medically significant) with onset 05Jan2021, outcome "recovered with sequelae"; NAUSEA (disability) with onset 05Jan2021, outcome "recovered with sequelae"; CHILLS (disability) with onset 05Jan2021, outcome "recovered with sequelae", described as "rigors"; SEIZURE (disability, medically significant) with onset 05Jan2021, outcome "recovered with sequelae", described as "seizure activity/witnessed syncopal episode with convulsive spells"; TACHYPNOEA (disability) with onset 05Jan2021, outcome "recovered with sequelae", described as "tachypneic"; VOMITING (disability) with onset 05Jan2021, outcome "recovered with sequelae"; SYNCOPE (disability, medically significant) with onset 05Jan2021, outcome "recovered with sequelae", described as "witnessed syncopal episode with convulsive spells/problem with concentration fainting"; HEADACHE (disability) with onset Jan2021, outcome "recovered with sequelae"; TREMOR (disability) with onset Jan2021, outcome "recovered with sequelae", described as "tremors"; SEIZURE (hospitalization, disability) with onset Sep2021, outcome "recovered with sequelae", described as "a major episode"; SPEECH DISORDER (disability), outcome "recovered with sequelae", described as "speech issues"; DISTURBANCE IN ATTENTION (disability), outcome "recovered with sequelae", described as "concentration issues"; FATIGUE (disability), outcome "recovered with sequelae"; MEMORY IMPAIRMENT (disability), outcome "recovered with sequelae", described as "forgetfulness". The event "seizure activity/witnessed syncopal episode with convulsive spells" required emergency room visit. The patient underwent the following laboratory tests and procedures: Blood calcium: (unspecified date) 8.5; Blood creatine phosphokinase: (unspecified date) normal; Blood lactic acid: (unspecified date) normal; Blood magnesium: (unspecified date) within normal limits; Blood potassium: (unspecified date) 3.2, notes: mild hypokalemia; Blood pressure measurement: (unspecified date) 150/97; (unspecified date) 111/64; (unspecified date) 116/69, notes: lying; (unspecified date) 127/77, notes: sitting; (unspecified date) 136/64, notes: standing; (05Jan2021) 111/64, notes: 12:00; (05Jan2021) 111/74, notes: 11:30; (05Jan2021) 113/65, notes: 11:10; (05Jan2021) 130/72, notes: 10:45; (05Jan2021) 130/72, notes: 10:20; (05Jan2021) 138/74, notes: 10:00; (05Jan2021) 134/76, notes: 09:50; (05Jan2021) 154/80, notes: 09:30; (05Jan2021) 150/97, notes: 09:00; Body mass index: (unspecified date) 40.0, notes: or higher (HCC); Body temperature: (unspecified date) 97.4, notes: degree F/36.3 degree C; (05Jan2021) 97.4, notes: degree F (36.3 degree C) at 09:22; Cardiac telemetry: (unspecified date) Unknown results, notes: Bedside Telemetry interpreted by patient in real time. Rate: 68. Rhythm: normal sinus rhythm. Premature Beats: None grossly Seen. A order for cardiac telemetry was ordered. Clinical reason for order: Other potential cardiac emergency not otherwise specified. with a general concern for dysrhythmia or cardiac abnormality. A general review of the patient's telemetry during this included encounter was consistent with normal sinus rhythm AND did not reveal any obvious clinically significant events, alarms or pertinent rhythms affecting outcomes; Full blood count: (unspecified date) Abnormal; Heart rate: (unspecified date) 84; (unspecified date) 64, notes: per minute; (unspecified date) 71, notes: per minute; (unspecified date) 82, notes: per minute; (unspecified date) 84; (05Jan2021) 84, notes: 12:00; (05Jan2021) 72, notes: 11:30; (05Jan2021) 61, notes: 11:10; (05Jan2021) 62, notes: 10:45; (05Jan2021) 67, notes: 10:20; (05Jan2021) 74, notes: 10:00; (05Jan2021) 76, notes: 09:51; (05Jan2021) 67, notes: 09:30; (05Jan2021) 84, notes: 09:00; Metabolic function test: (unspecified date) Abnormal; Oxygen saturation: (unspecified date) Unknown results, notes: An order for general oxygen monitoring and oximetry was ordered. Clinical reason for order was for potential for hypoxia, respiratory insufficiency due to potential emergent conditions being evaluated for or being treated for. A general review of the patient's oximetry during this included encounter did not reveal any clinically pertinent hypoxic events affecting clinical outcome or requiring intervention; Oxygen saturation: (unspecified date) 100 %; (unspecified date) 100 %; (05Jan2021) 100 %, notes: 12:00; (05Jan2021) 99 %, notes: 11:30; (05Jan2021) 98 %, notes: 11:10; (05Jan2021) 100 %, notes: 10:45; (05Jan2021) 100 %, notes: 10:20; (05Jan2021) 100 %, notes: 10:00; (05Jan2021) 97 %, notes: 09:51; (05Jan2021) 98 %, notes: 09:50; (05Jan2021) 96 %, notes: 09:30; (05Jan2021) 100 %, notes: 09:22; HENT: (unspecified date) Head: Normocephalic and atraumatic, notes: Mouth/Throat: Oropharynx is clear and moist. Eyes: Pupils are equal, round, and reactive to light. No scleral icterus. Neck: Normal range of motion. Neck supple. Cardiovascular: Normal rate, regular rhythm, normal heart sounds and intact distal pulses. Pulmonary/Chest: Effort normal and breath sounds normal. Tachypnea noted. No respiratory distress. Abdominal: Soft. There is no abdominal tenderness. There is no rebound. Musculoskeletal: Normal range of motion. No tenderness or edema. Neurological: She is alert and oriented to person, place, and time. GCS eye subscore is 4. GCS verbal subscore is 5. GCS motor subscore is 6. Following commands and responding to verbal stimuli. Skin: Skin is warm and dry. No rash noted. Psychiatric: She has a normal mood and affect. Her behavior is normal; Respiratory rate: (unspecified date) 38; (unspecified date) 18; (05Jan2021) 18, notes: 12:00; (05Jan2021) 26, notes: 11:30; (05Jan2021) 15, notes: 11:10; (05Jan2021) 23, notes: 10:45; (05Jan2021) 20, notes: 10:20; (05Jan2021) 23, notes: 10:00; (05Jan2021) 15, notes: 09:51; (05Jan2021) 17, notes: 09:30; (05Jan2021) 38, notes: 09:22; White blood cell count: (unspecified date) 11.5; (unspecified date) Constitutional: appears morbidly Obese. No distress. Clinical course included: the patient had been having issues ever since vaccination. Within minutes after receiving the vaccine the patient started having seizure activity and ended up in the emergency room. Everything was witnessed by hospital employees. The patient continued to be uncontrolled seizure activity that medication is not helping. She was unable to work because of this beside seizure activity, the patient had forgetfulness, speech issues, fatigue, concentration issues and more. The brief event was reported as Allergic reaction, loss of consciousness, past injection dizzy, nausea lightheaded, witnessed syncopal episode with convulsive spells and vomiting. This event happened in Jan2021 and continue to have issues like, tremors, headache, light headedness, problem with concentration fainting, speech problems and etc. In Sep2021 while at work finishing up her shift she had a major episode of the nurses station which end up with hospital admission of 4 to 5. The patient had not being able to work since. The patient presenting to the ED (Emergency Department) as rapid Response with c/o (complaining of) allergic reaction which began just pta (prior to arrival). The patient is an employee at this hospital. The received Covid vaccination this morning and began feeling dizzy, lightheaded and then had an unanticipated medical event. The patient had a witnessed syncopal episode with seizure-like activity with convulsive spells and vomiting. She was moved from chair onto floor as precautions. She also began feeling nauseous with emesis. She was then moved into the emergency room as part of the rapid response protocol. Patient denies any h/o (history of) seizure. Patient was in process of talking with mother over the phone before demonstrating seizure-like activity again while in ED room. Allergic Reaction: The illness progression has not changed. The symptoms are associated with new medications. The associated symptoms include nausea and vomiting. The vomiting frequency was once. The vomit appearance was stomach contents. No treatments have been tried. The patient has no history of similar symptoms previously. There are no sick contacts. The patient has not received any recent medical care. The patient presented to the ED for evaluation of potential reaction following Covid-19 vaccination. Symptoms were onset almost immediately after the shot. She had loss of consciousness with seizure like activity and vomiting. Patient brought to ER (emergency room) where convulsive like behavior is ongoing. VS tachypneic but improved. Upon examination, patient arrives nauseous with rigors and convulsions but still able to follow commands and respond to verbal stimuli. Appropriate PPE worn throughout patient encounter. Differential diagnosis includes allergic reaction, anaphylaxis, epilepsy, electrolyte abnormality, dehydration among others. Seizure precautions: IV Ativan, Benadryl; IV LR bolus infusion. Lab work grossly WNCL with the exception of mild hypokalemia. Lactate and CK normal. 10:25 AM: Patient feeling significantly improved and resting comfortably in no distress after ativan and benadryl. No more convulsions or seizure like activity after the fluids, ativan and benadryl. 1:28 pm: Patient feeling at baseline. No reoccurrence during ED observation. No evidence of dehydration. No respiratory distress. Tolerating PO. No focal neuro deficits. She is ambulatory at this time and again feeling much better and back to baseline. Patient in no distress, and stable for dispo home. Patient nontoxic appearing, afebrile. Not sure if after this reaction to the 1st covid 19 vaccine shot she will be allowed to get the 2nd shot. Final diagnoses reported as Vaccine reaction, initial encounter. S/P (Status Post) Vaccination to the Covid-19 Virus. It was reported that the events resulted in disability or permanent damage. Outcome provided as Recovered/Resolved with lasting effects. ED Interventions included: Medications: LORazepam (ATMAN) injection 1 mg (has no administration in time range); LORazepam (ATIVAN) 2 mg/ml- injection -ADS; Override Pull (override Pull 05Jan2021 09:19); diphenhydramine (BENADRYL) 50 mg/mL; injection -ADS Override Pull (Override Pull 05Jan2021 09:20); Lorazepam (ATIVAN) injection 2 mg (2 mg Intravenous Given 05Jan2021 09:00); diphenhydramine (BENADRYL) injection 50 mg (50 mg Intravenous Given 05Jan2021 09:00); 0.9% sodium chloride (NaCl) 1,000 mL bolus (Intravenous Completed 05Jan2021 11:00); lactated ringers (LR) IV 500 mL (0 mLs Intravenous Completed 05Jan2021 12:02); potassium bicarbonate (K-LYTE) 25 MEQ disintegrating tablet 25 mEq (25 mEq Oral Given 05Jan2021 12:01).; Sender's Comments: There is a reasonable possibility that the events dizziness, nausea, vomiting, syncope, anaphylactic reaction, headache, chills, and fatigue were related to BNT162b2 based on known drug safety profile. Based on the temporal relationship, the association between the other events with BNT162b2 can not be fully excluded. 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.

Medical history

Medical History/Concurrent Conditions: Achilles tendinitis; Alcohol use (Frequency: Monthly or less Drinks per session: 1 or 2); Arthritis; Carpal tunnel release; Cholecystectomy; Contracture of tendon (sheath); Depression; Essential hypertension (Hypertension; Relation: Mother, Father, Brother, Maternal Aunt, Maternal Uncle); Fibromyalgia; Ganglion removal; Gastrocnemius equinus; GERD; Knee arthroscopy (Literality: Bilateral Literality: Right); Morbid obesity (with body mass index (BMI) of 40.0 or higher (HCC)); Non-smoker (Smokeless tobacco: Never used Substance use topics); Peripheral sensory neuropathy; Rheumatoid arthritis; Seasonal allergy; Thyroidectomy partial (Literality: Right); Tobacco user; Tonsillectomy; Tooth extraction; Vitamin D deficiency

Other medications

ZOLOFT; PROTONIX [OMEPRAZOLE]; MOBIC; NORVASC; VITAMIN D2

Lab data

Test Name: Calcium; Result Unstructured Data: Test Result:8.5; Test Name: CK; Result Unstructured Data: Test Result:normal; Test Name: Lactate; Result Unstructured Data: Test Result:normal; Test Name: Magnesium; Result Unstructured Data: Test Result:within normal limits; Test Name: Potassium; Result Unstructured Data: Test Result:3.2; Comments: mild hypokalemia; Test Name: BP; Result Unstructured Data: Test Result:150/97; Test Name: BP; Result Unstructured Data: Test Result:111/64; Test Name: BP; Result Unstructured Data: Test Result:116/69; Comments: lying; Test Name: BP; Result Unstructured Data: Test Result:127/77; Comments: sitting; Test Name: BP; Result Unstructured Data: Test Result:136/64; Comments: standing; Test Date: 20210105; Test Name: BP; Result Unstructured Data: Test Result:111/64; Comments: 12:00; Test Date: 20210105; Test Name: BP; Result Unstructured Data: Test Result:111/74; Comments: 11:30; Test Date: 20210105; Test Name: BP; Result Unstructured Data: Test Result:113/65; Comments: 11:10; Test Date: 20210105; Test Name: BP; Result Unstructured Data: Test Result:130/72; Comments: 10:45; Test Date: 20210105; Test Name: BP; Result Unstructured Data: Test Result:130/72; Comments: 10:20; Test Date: 20210105; Test Name: BP; Result Unstructured Data: Test Result:138/74; Comments: 10:00; Test Date: 20210105; Test Name: BP; Result Unstructured Data: Test Result:134/76; Comments: 09:50; Test Date: 20210105; Test Name: BP; Result Unstructured Data: Test Result:154/80; Comments: 09:30; Test Date: 20210105; Test Name: BP; Result Unstructured Data: Test Result:150/97; Comments: 09:00; Test Name: body mass index (BMI); Result Unstructured Data: Test Result:40.0; Comments: or higher (HCC); Test Name: Temperature; Result Unstructured Data: Test Result:97.4; Comments: degree F/36.3 degree C; Test Date: 20210105; Test Name: Temperature; Result Unstructured Data: Test Result:97.4; Comments: degree F (36.3 degree C) at 09:22; Test Name: cardiac telemetry; Result Unstructured Data: Test Result:Unknown results; Comments: Bedside Telemetry interpreted by patient in real time. Rate: 68. Rhythm: normal sinus rhythm. Premature Beats: None grossly Seen. A order for cardiac telemetry was ordered. Clinical reason for order: Other potential cardiac emergency not otherwise specified. with a general concern for dysrhythmia or cardiac abnormality. A general review of the patient's telemetry during this included encounter was consistent with normal sinus rhythm AND did not reveal any obvious clinically significant events, alarms or pertinent rhythms affecting outcomes; Test Name: CBC with differential; Result Unstructured Data: Test Result:Abnormal; Test Name: Pulse; Result Unstructured Data: Test Result:84; Test Name: Pulse; Result Unstructured Data: Test Result:64; Comments: per minute; Test Name: Pulse; Result Unstructured Data: Test Result:71; Comments: per minute; Test Name: Pulse; Result Unstructured Data: Test Result:82; Comments: per minute; Test Name: Pulse; Result Unstructured Data: Test Result:84; Test Date: 20210105; Test Name: Pulse; Result Unstructured Data: Test Result:84; Comments: 12:00; Test Date: 20210105; Test Name: Pulse; Result Unstructured Data: Test Result:72; Comments: 11:30; Test Date: 20210105; Test Name: Pulse; Result Unstructured Data: Test Result:61; Comments: 11:10; Test Date: 20210105; Test Name: Pulse; Result Unstructured Data: Test Result:62; Comments: 10:45; Test Date: 20210105; Test Name: Pulse; Result Unstructured Data: Test Result:67; Comments: 10:20; Test Date: 20210105; Test Name: Pulse; Result Unstructured Data: Test Result:74; Comments: 10:00; Test Date: 20210105; Test Name: Pulse; Result Unstructured Data: Test Result:76; Comments: 09:51; Test Date: 20210105; Test Name: Pulse; Result Unstructured Data: Test Result:67; Comments: 09:30; Test Date: 20210105; Test Name: Pulse; Result Unstructured Data: Test Result:84; Comments: 09:00; Test Name: comprehensive metabolic panel; Result Unstructured Data: Test Result:Abnormal; Test Name: oximetry; Result Unstructured Data: Test Result:Unknown results; Comments: An order for general oxygen monitoring and oximetry was ordered. Clinical reason for order was for potential for hypoxia, respiratory insufficiency due to potential emergent conditions being evaluated for or being treated for. A general review of the patient's oximetry during this included encounter did not reveal any clinically pertinent hypoxic events affecting clinical outcome or requiring intervention; Test Name: SpO2; Test Result: 100 %; Test Name: SpO2; Test Result: 100 %; Test Date: 20210105; Test Name: SpO2; Test Result: 100 %; Comments: 12:00; Test Date: 20210105; Test Name: SpO2; Test Result: 99 %; Comments: 11:30; Test Date: 20210105; Test Name: SpO2; Test Result: 98 %; Comments: 11:10; Test Date: 20210105; Test Name: SpO2; Test Result: 100 %; Comments: 10:45; Test Date: 20210105; Test Name: SpO2; Test Result: 100 %; Comments: 10:20; Test Date: 20210105; Test Name: SpO2; Test Result: 100 %; Comments: 10:00; Test Date: 20210105; Test Name: SpO2; Test Result: 97 %; Comments: 09:51; Test Date: 20210105; Test Name: SpO2; Test Result: 98 %; Comments: 09:50; Test Date: 20210105; Test Name: SpO2; Test Result: 96 %; Comments: 09:30; Test Date: 20210105; Test Name: SpO2; Test Result: 100 %; Comments: 09:22; Test Name: HENT; Result Unstructured Data: Test Result:Head: Normocephalic and atraumatic; Comments: Mouth/Throat: Oropharynx is clear and moist. Eyes: Pupils are equal, round, and reactive to light. No scleral icterus. Neck: Normal range of motion. Neck supple. Cardiovascular: Normal rate, regular rhythm, normal heart sounds and intact distal pulses. Pulmonary/Chest: Effort normal and breath sounds normal. Tachypnea noted. No respiratory distress. Abdominal: Soft. There is no abdominal tenderness. There is no rebound. Musculoskeletal: Normal range of motion. No tenderness or edema. Neurological: She is alert and oriented to person, place, and time. GCS eye subscore is 4. GCS verbal subscore is 5. GCS motor subscore is 6. Following commands and responding to verbal stimuli. Skin: Skin is warm and dry. No rash noted Psychiatric: She has a normal mood and affect. Her behavior is normal.; Test Name: Physical Exam; Result Unstructured Data: Test Result:Constitutional: appears morbidly Obese.No distress; Test Name: Resp; Result Unstructured Data: Test Result:38; Test Name: Resp; Result Unstructured Data: Test Result:18; Test Date: 20210105; Test Name: Resp; Result Unstructured Data: Test Result:18; Comments: 12:00; Test Date: 20210105; Test Name: Resp; Result Unstructured Data: Test Result:26; Comments: 11:30; Test Date: 20210105; Test Name: Resp; Result Unstructured Data: Test Result:15; Comments: 11:10; Test Date: 20210105; Test Name: Resp; Result Unstructured Data: Test Result:23; Comments: 10:45; Test Date: 20210105; Test Name: Resp; Result Unstructured Data: Test Result:20; Comments: 10:20; Test Date: 20210105; Test Name: Resp; Result Unstructured Data: Test Result:23; Comments: 10:00; Test Date: 20210105; Test Name: Resp; Result Unstructured Data: Test Result:15; Comments: 09:51; Test Date: 20210105; Test Name: Resp; Result Unstructured Data: Test Result:17; Comments: 09:30; Test Date: 20210105; Test Name: Resp; Result Unstructured Data: Test Result:38; Comments: 09:22; Test Name: WBC; Result Unstructured Data: Test Result:11.5