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From the 7/23/2021 release of VAERS data:

Found 506,830 cases where Vaccine is COVID19 and Patient Did Not Die



Case Details (Reverse Sorted by Onset Date)

This is page 279 out of 5,069

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VAERS ID: 1409119 (history)  
Form: Version 2.0  
Age: 79.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7338 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Headache, Pruritus, Rash, Rhinorrhoea
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data: Test Date: 20210601; Test Name: body temperature; Result Unstructured Data: Test Result:36.5; Comments: before vaccination
CDC Split Type: JPPFIZER INC2021647116

Write-up: Itchy skin and skin eruption appeared in the upper body; Itchy skin and skin eruption appeared in the upper body; headache; Serous nasal discharge; This is a spontaneous report from the contactable physician received from the Agency. Regulatory authority report number is v21111088. The patient was 79-year and 3-month-old female. Body temperature before the vaccinations was 36.5 degrees centigrade. The patient''s history according to the Vaccine Screening Questionnaire (including underlying diseases, allergies, vaccinations received or diseases developed within the last month, medications used, past adverse drug reaction history, and growth status) included the patient was none. Concomitant drug was not reported. On 01Jun2021 at 10:00 (the day of vaccination) at age of 79-year-old, the patient received the first dose of bnt162b2 (COMIRNATY Intramuscular injection, Lot number: FA7338, expiration date:30Sep2021) via an unspecified route of administration as a single dose for COVID-19 immunization. The event terms were reported as headache, skin eruption and nasal discharge. The date and time of onset was provided as 15:00 on 01Jun2021. Clinical course of the event was reported as follows: About five hours after the vaccination of comirnaty, the patient experienced itchy skin and skin eruption appeared in the upper body. At the same time, the symptoms of headache and serous nasal discharge appeared.When the patient came to the hospital today (as reported), it was judged that it was an adverse reaction, and the antihistamine allelock and the antipyretic analgesic loxonin were prescribed for 3 days. The total counts of red blood cells and the biochemical structure and characteristics were currently being confirmed. The outcome of the events was not recovered on 02Jun2021. (one day after vaccination). The reporter classified the event as non-serious and the causality between the event and the vaccines was related. Other possible cause of the event such as any other diseases was no. The reporter comments as follows: symptoms appeared in a relatively short period of time (5 hours after vaccination), and there was no other underlying disease. Therefore, it was very likely to be judged as an adverse reaction of the vaccine.


VAERS ID: 1409129 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA5765 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthma
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: ROSUVASTATIN; OLMESARTAN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma bronchial; Food allergy; Hyperlipidaemia; Hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021647850

Write-up: Asthma bronchial; This is a spontaneous report from a contactable physician. The patient was a non-pregnant elderly female. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received Rosuvastatin, Olmesartan and others within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had allergies to soba. Other medical history included asthma bronchial, hypertension and hyperlipidaemia. On 01Jun2021 at 15:15 (the day of vaccination), the patient received the first single dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number FA5765, Expiration date 30Sep2021) intramuscular in the left arm for COVID-19 immunization. On 01Jun2021 at 15:15 (the day of vaccination), the patient experienced asthma bronchial. The event resulted in emergency room/department or urgent care. The outcome of the event was recoved with a treatment including Adrenaline, Solu-Cortef, infusion. Since the vaccination, the patient has not been tested for COVID-19.


VAERS ID: 1409154 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY5420 / 1 RA / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Angioedema, Auscultation, Blood pressure measurement, Body temperature, Heart rate, Investigation, Oxygen saturation, Vital signs measurement
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Oropharyngeal allergic conditions (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210601; Test Name: Chest auscultation; Result Unstructured Data: Test Result:no problem; Comments: at 12:10; Test Date: 20210601; Test Name: BP; Result Unstructured Data: Test Result:155/94 mmHg; Comments: at 11:20; Test Date: 20210601; Test Name: Body temperature; Result Unstructured Data: Test Result:36.5 Centigrade; Comments: before vaccination; Test Date: 20210601; Test Name: Body temperature; Result Unstructured Data: Test Result:36.8 Centigrade; Comments: at 11:20; Test Date: 20210601; Test Name: HR; Result Unstructured Data: Test Result:77/minute; Comments: at 11:20; Test Date: 20210601; Test Name: Examination; Result Unstructured Data: Test Result:revealed no apparent skin symptoms (no redness, wh; Comments: at 12:10 revealed no apparent skin symptoms (no redness, wheals, or skin eruption), no hyperaemia of bulbar conjunctiva, lips, or oral mucosa, no gastrointestinal symptoms, and no respiratory distress.; Test Date: 20210601; Test Name: Examination; Result Unstructured Data: Test Result:no skin symptoms including the right palm and no m; Comments: At 12:15 no skin symptoms including the right palm and no mucosal symptoms or oedema; Test Date: 20210601; Test Name: SpO2; Test Result: 99 %; Comments: room; at 11:20; Test Date: 20210601; Test Name: vital signs; Result Unstructured Data: Test Result:no problem in vital signs; Comments: At 11:58 At 12:15 At 12:35 At 13:55
CDC Split Type: JPPFIZER INC2021650532

Write-up: angioedema; Anaphylaxis; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21111334. The patient was a 46-year and 3-month-old female. Body temperature before vaccination was 36.5 degrees centigrade. Family history was unknown. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). On 01Jun2021 at 11:10 (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EY5420, Expiration date 31Aug2021) via an unspecified route of administration in right upper arm at age of 46 years old as a single dose for COVID-19 immunization. On 01Jun2021 at 11:15 (5 minutes after the vaccination), the patient experienced anaphylaxis. On 01Jun2021 at 11:58 (48 minutes after the vaccination), the patient experienced angioedema. On 01Jun2021 (on the same day of the vaccination), the outcome of the events was recovering. The course of the event was as follows: At 11:10, the patient received the first dose of COMIRNATY manufactured by Pfizer in right upper arm. Immediately after that, at around 11:15, the patient noticed redness of the right palm. At 11:20, the patient developed pallor facial, cold sweat, and malaise, for which the patient was placed at bed rest in the left lateral position and started to be followed-up. Vital signs measured at that time included blood pressure of 155/94 mmHg, heart rate of 77/minute, SpO2 of 99% (room), and body temperature of 36.8 degrees centigrade. It was instructed to measure vital signs every 5 minutes and there was no problem. At 11:58, there was no problem in vital signs. The patient complained of oedema in the area surrounding right cheek to auricle and had subjective symptom of flash vision of the right eye. At 12:10, there was no change in blood pressure or vital signs; however, the patient had subjective symptom of heaviness in the right arm, complained of oedema in the area surrounding right cheek to auricle, and continued to complain of flash vision of the right eye. Examination revealed no apparent skin symptoms (no redness, wheals, or skin eruption), no hyperaemia of bulbar conjunctiva, lips, or oral mucosa, no gastrointestinal symptoms, and no respiratory distress. Chest auscultation found no problem. At 12:15, there was no problem in vital signs and the patient had no respiratory distress. Examination found no skin symptoms including the right palm and no mucosal symptoms or oedema. However, subjective symptoms were persistent, for which the patient was instructed to take ALLEGRA 60 mg 1 tablet orally. At 12:35, there was no problem in vital signs and the patient had no respiratory distress. Subjective symptom of oedema in the area surrounding right cheek to auricle persisted, for which route was secured with 22G surflo in the left forearm peripheral vein and intravenous injection of POLARAMINE 5 mg + physiological saline 100 mg was initiated. At 12:38, the symptoms did not aggravate; however, subjective symptom persisted. Adrenaline was not used since there was no fluctuation in blood pressure and respiratory distress was absent. Since there was a concern of occurrence of persistent allergy, intravenously injection of SOLU-CORTEF 250 mg 1V + physiological saline 100 mL was initiated. At 13:55, there was no problem in vital signs. Injection was completed and subjective symptom of face oedema improved. Also, malaise and cold sweat disappeared and needle was removed. The patient was followed-up for another 1 hour and had no problem in physical condition; thus, the patient returned home. The patient was instructed to take ALLEGRA 60 mg 1 tablet orally again in the evening. The patient was instructed to contact the physician to consult if respiratory distress, wheezing, pharynx itchy sensation of, mucosal symptom, or urticaria occurred after returning home as well as to request ambulance without hesitation in emergency. Anaphylaxis, persistent allergy (intravenous injection of SOLU-CORTEF 250 mg 1V + physiological saline 100 mL), angioedema (intravenous injection of POLARAMINE 5 mg + physiological saline 100 mg), headache (acetaminophen 500 mg was prescribed to be taken orally at the time of headache), and urticaria (ALLEGRA 60 mg 2 tablets twice daily for 7 days were prescribed). The reporting physician classified the event as non-serious and assessed that the event was related to BNT162b2. There was no other possible cause of the event such as any other diseases. The reporting physician commented as follows: Symptoms appeared 5 minutes after the vaccination; thus, it was considered to be related to the vaccine.


VAERS ID: 1409156 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY5420 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement, Body temperature, Erythema, Heart rate, Oxygen saturation, Pruritus
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Hypertension (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210601; Test Name: BP; Result Unstructured Data: Test Result:140/85; Comments: at 16:28; Test Date: 20210601; Test Name: BP; Result Unstructured Data: Test Result:148-88; Comments: at 16:00; Test Date: 20210601; Test Name: body temperature; Result Unstructured Data: Test Result:36.3 Centigrade; Comments: before vaccine; Test Date: 20210601; Test Name: HR; Result Unstructured Data: Test Result:82; Comments: at 16:28; Test Date: 20210601; Test Name: HR; Result Unstructured Data: Test Result:82; Comments: at 16:00; Test Date: 20210601; Test Name: SpO2; Test Result: 96 %; Comments: at 16:28; Test Date: 20210601; Test Name: SpO2; Test Result: 98 %; Comments: at 16:00
CDC Split Type: JPPFIZER INC2021650542

Write-up: Upper body itching; redness; BP 148-88; This is a spontaneous report from a contactable nurse received from the Regulatory authority report number is v21110917. The patient was a 53-year and 11-month-old female (at event onset date and vaccination date). Body temperature before vaccination was 36.3 degrees Centigrade on 01Jun2021. The patient had no family history. There were some points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). On 01Jun2021 at 15:10 (the day of vaccination), the patient received the first dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number EY5420, Expiration date 31Aug2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On 01Jun2021 at 16:00 (50 minutes after the vaccination), the patient experienced Upper body itching, redness. The course of the event was as follows: 16:00, Upper body itching keep existed. BP148-88, SpO2 98%, HR 82. 16:10, according the doctor comment, normal saline 500ml and POLARAMINE 5mg Intravenous injected in the left upper arm. 16:28, BP 140/85, SpO2 96%, HR 82, treatment stopped. Upper body itching, redness disappeared. The reporting nurse classified the event as non-serious and did not provide the causality between the event and BNT162B2. The reporting nurse commented as follows: Considering the Chest itching, treated with POLARAMINE div and improved, patient went home. The patient was told to come to the doctor again if symptoms appear again or respiratory tract symptoms, circulatory system symptoms appear. On 01Jun2021, the outcome of the events was recovering.


VAERS ID: 1409159 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-31
Onset:2021-06-01
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7338 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Dizziness, Magnetic resonance imaging, Nausea
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none
Allergies:
Diagnostic Lab Data: Test Date: 20210531; Test Name: Body temperature; Result Unstructured Data: Test Result:36.6 Centigrade; Comments: before vaccine; Test Date: 20210601; Test Name: MRI; Result Unstructured Data: Test Result:no abnormal
CDC Split Type: JPPFIZER INC2021650569

Write-up: Giddiness; Queasy; This is a spontaneous report from a contactable healthcare professional received from the regulatory authority. Regulatory authority report number is v21111279. The patient was a 67-year female. Body temperature before vaccination was 36.6 degrees Centigrade. The patient had no family history. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). On 31May2021 at 15:30 (the day of vaccination), the patient received the first dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number FA7338, Expiration date 30Sep2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On 01Jun2021 at 12:00 (20 hours 30 minutes after the vaccination), the patient experienced Queasy, Giddiness. On 01Jun2021, the patient went to hospital emergency outpatient consultation. On 01Jun2021, the outcome of the events was recovered. The course of the event was as follows: On 31May2021, Coronavirus vaccination. On 01Jun2021, from noon, Giddiness and Queasy occurred, hospital emergency outpatient consultation, no abnormal on head MRI, Intravenous (SOLDEM 3A200ml+ POLARAMINE 5ml/A Primperan/A iv). After that, symptom recovered, went home. The reporting other HCP classified the event as non-serious and assessed that the event was related to BNT162B2. There was no other possible cause of the event such as any other diseases. The reporting other HCP commented as follows: It is considered to be a side effect of the vaccine, but it is not considered to be particularly serious.


VAERS ID: 1409160 (history)  
Form: Version 2.0  
Age: 66.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY5420 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Blood pressure measurement, Body temperature, Heart rate, Oxygen saturation
SMQs:, Anaphylactic reaction (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypersensitivity (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: SODIUM VALPROATE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dementia Alzheimer''s type
Allergies:
Diagnostic Lab Data: Test Date: 20210601; Test Name: BP; Result Unstructured Data: Test Result:138/78; Comments: after vaccination; Test Date: 20210601; Test Name: Body temperature/KT; Result Unstructured Data: Test Result:36.7 Centigrade; Comments: before vaccination; Test Date: 20210601; Test Name: Body temperature/KT; Result Unstructured Data: Test Result:37.2 Centigrade; Comments: after vaccination; Test Date: 20210601; Test Name: P; Result Unstructured Data: Test Result:99 times/min; Comments: after vaccination; Test Date: 20210601; Test Name: SpO2; Test Result: 99 %; Comments: after vaccination
CDC Split Type: JPPFIZER INC2021650570

Write-up: Anaphylaxis; This is a spontaneous report from a contactable physician received from the Pharmaceuticals and Medical Devices Agency (PMDA). Regulatory authority report number is v21111439. The patient was a 66-year and 11-month-old male. Body temperature before vaccination was 36.7 degrees centigrade. Family history was not reported. Medical history included early-onset Alzheimer''s type dementia. Concomitant medications included sodium valproate (being taken orally). On 01Jun2021 at 09:50 (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EY5420, Expiration date 31Aug2021) intramuscularly in left upper arm as a single dose for COVID-19 immunisation. On 01Jun2021 at 10:15 (25 minutes after the vaccination), the patient experienced anaphylaxis. On 02Jun2021 (1 day after the vaccination), the outcome of the event was recovering. The course of the event was as follows: On 01Jun2021 at 09:50 (the day of vaccination), the patient received BNT162b2 intramuscularly into the left upper arm. At 10:15 (25 minutes after the vaccination), feeling hot of the body and skin red in the face and chest were present. The staff found the patient moving his extremities wildly on the bed. The reporting physician examined the patient. The blood pressure (BP) was 138/78, the pulse (P) 99 times/min, the SpO2 99%, and the body temperature (KT) 37.2 degrees centigrade. Body movements were violent, and cooling was started. No respiratory symptoms were noted. No wheezing was observed. At 11:10 (1 hour and 20 minutes after the vaccination), redness in the face and chest was persisting, and a rapid infusion of normal saline 100 mL + hydrocortisone sodium phosphate 200 mg and an infusion of normal saline 500 mL + POLARAMINE 1A were performed. Dermatologic symptoms and unrest immediately disappeared. The reporting physician classified the event as non-serious and assessed that the event was related to BNT162b2. There was no other possible cause of the event such as any other diseases. The reporting physician commented as follows: Nothing in particular.


VAERS ID: 1409181 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA2453 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Blood pressure decreased, Blood pressure measurement, Body temperature, Chills, Cough, Heart rate, Malaise, Oropharyngeal discomfort, Rash, Somnolence, Tachycardia, Tremor
SMQs:, Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Dementia (broad), Parkinson-like events (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergy to antibiotic; Cough variant asthma; Fruit allergy
Allergies:
Diagnostic Lab Data: Test Date: 20210601; Test Name: blood pressure; Result Unstructured Data: Test Result:blood pressure decreased; Comments: at about 12:00; Test Date: 20210601; Test Name: body temperature; Result Unstructured Data: Test Result:36.6 Centigrade; Comments: before vaccination; Test Date: 20210601; Test Name: heart rate; Result Unstructured Data: Test Result:about 95; Comments: at about 12:00
CDC Split Type: JPPFIZER INC2021650996

Write-up: Anaphylaxis; chills; Sleepiness; malaise; Tremor; Tachycardia at heart rate about 95; Blood pressure decreased; Pharynx strange sensation/Pharynx discomfort; cough; Skin eruption; This is a spontaneous report from a contactable Other Health Professional received from the Medical Devices Agency (MDA). Regulatory authority report number is v21111434. The patient was a 46-year and 6-month-old female received the first dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number FA2453, Expiration date 31Aug2021) via an unspecified route of administration on 01Jun2021 at 10:34 (the day of vaccination, at age of 46 years old) as 1st dose, single for COVID-19 immunisation. Medical history included cough variant asthma, allergy to antibiotic, melon allergy. Body temperature before vaccination was 36.6 degrees Centigrade on 01Jun2021. Concomitant was not reported. The course of the events was as follows: The event onset date was reported as 01Jun2021 at 11:15 (41 minutes after the vaccination) (as reported). On 01Jun2021 around 11:15(41 minutes after the vaccination), the patient experienced pharynx strange sensation, cough, Skin eruption, pharynx discomfort. On 01Jun2021 around 11:28(54 minutes after the vaccination), the patient took ADRENALINE0.3 mg. Then the patient was prescribed medicine with RINDERON, POLARAMINE. Skin eruption faded and slowly disappeared. On 01Jun2021 around 11:45(1 hour 11 minutes after the vaccination), the pharynx discomfort disappeared too. On 01Jun2021 around 12:00(1 hour 26 minutes after the vaccination), the patient did not experience chills, but started to tremor. The patient experienced blood pressure decreased and tachycardia with the heart rate of about 95, both on 01Jun2021 12:00. As an anaphylaxis, but also in order to prevent biphasic response, the patient was hospitalized for observation one night. On 02Jun2021 (1 day after the vaccination), the patient still had sleepiness and malaise, but due to the improvement of other conditions (as reported), the patient was discharged. The outcome of anaphylaxis, cough, tremor, tachycardia at heart rate about 95, blood pressure decreased was recovered on 02Jun2021. The outcome of Skin eruption was recovered 01Jun2021 11:28. The outcome of Pharynx strange sensation/Pharynx discomfort was recovered on 01Jun2021 11:45. The outcome of chills was recovered on 01Jun2021 12:00. The outcome of sleepiness and malaise was not recovered. The reporting Other Health Professional classified the events as non-serious and assessed that the events were related to BNT162B2. There was no other possible cause of the events such as any other diseases.


VAERS ID: 1409185 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Body temperature, Body temperature increased, Dizziness, Guillain-Barre syndrome, Muscular weakness
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (narrow), Noninfectious encephalopathy/delirium (broad), Demyelination (narrow), Vestibular disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data: Test Date: 20210601; Test Name: Body temperature; Result Unstructured Data: Test Result:37.6 Centigrade; Comments: 13:00
CDC Split Type: JPPFIZER INC2021651027

Write-up: Swaying feeling; Weakness; Body temperature increased at 37.6 centigrade; Progressive weakness of the limbs; Guillain-Barre syndrome; This is a spontaneous report from a contactable physician in charge received from the Regulatory Authority. Regulatory authority report number is v21111345. The patient was a 43-year and 9-month-old (as reported) female. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). On 01Jun2021 at 12:20 (the day of vaccination), the patient received the second dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number xxx, as reported), at the age of 43-year-old, as a single dose for COVID-19 immunization. On 01Jun2021 at 13:00 (40 minutes after the vaccination), the patient experienced Swaying feeling, Weakness, Body temperature increased at 37.6 centigrade, Progressive weakness of the limbs, Guillain-Barre syndrome. On 02Jun2021 (around 1 day after the vaccination), the outcome of the event not recovered. The course of the event was as follows: About 40 minutes after vaccination, Swaying feeling and Weakness appeared, Body temperature increased at 37.6 centigrade, then progressive weakness of limbs appeared. Symptoms progressed to about 1 hour and 40 minutes after vaccination. After that, although no deterioration was observed, no improvement tendency was observed, so Methylprednisolone 120 mg was administered. After that, the symptoms gradually improved and it became possible to maintain the sitting position in about 1 hour. The reporting physician in charge classified the event as serious (medically significant which reported as ''can lead to disability'') and assessed that the event was related to BNT162B2. There was no other possible cause of the event such as any other diseases. The reporting physician in charge commented as follows: A naturally healthy woman, symptoms appeared 40 minutes after the second ingestion and the symptoms progressed relatively rapidly. Although no effect on respiratory circulation was observed, vaccination was judged to be related because steroid were administered for rapid symptom progression and improvement was observed. We plan to keep an eye on future changes in symptoms. Information on the lot/batch number has been requested.


VAERS ID: 1409188 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY0779 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Body temperature, Feeling hot, Hyperhidrosis, Pyrexia, Tachycardia, Tremor
SMQs:, Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Rhinitis allergic
Allergies:
Diagnostic Lab Data: Test Date: 20210601; Test Name: body temperature; Result Unstructured Data: Test Result:38 Centigrade
CDC Split Type: JPPFIZER INC2021651191

Write-up: Anaphylaxis; hot feeling with the body; sweaty; Tachycardia; Tremulousness; Pyrexia at 38 centigrade degree; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v2111109. The patient was a 36-year and 1-month-old female. The patient had the history of rhinitis allergic. The concomitant medications were not reported. On 01Jun2021 at 15:40 (the day of vaccination) at 36-years old, the patient received second dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number EY0779, Expiration date 31Aug2021) for COVID-19 immunization. On 01Jun2021 at 15:40 (the day of vaccination), the patient experienced hot feeling with the body, sweaty, tachycardia and Tremulousness. On 02Jun2021 (1 day after the vaccination), the outcome of the events were recovered on 02Jun2021. The course of the event was as follows: After the vaccination, the patient experienced hot feeling with the body, sweaty, tachycardia and Tremulousness, and the patient received 0.3 mg of Adrenaline for Intramuscular injection, RINDERON 4mg and physiological saline 100ml for intravenous infusion. Due to the symptoms improved, the patient returned home. The patient experienced Pyrexia at 38 centigrade degree when returned home on 01Jun2021, and then the symptom improved naturally. This report meets the criteria of Anaphylaxis. The reporting physician classified the events as non-serious and assessed that the event was related to BNT162B2. There was no other possible cause of the events such as any other diseases.The reporting physician commented as follows: The reporter thought there was high possibility of side effects after vaccination.


VAERS ID: 1409199 (history)  
Form: Version 2.0  
Age: 54.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY0779 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Body temperature, Heart rate, Oxygen saturation, Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210601; Test Name: blood pressure; Result Unstructured Data: Test Result:130/67 mmHg; Test Date: 20210601; Test Name: body temperature; Result Unstructured Data: Test Result:35.8 Centigrade; Comments: before vaccination; Test Date: 20210601; Test Name: body temperature; Result Unstructured Data: Test Result:35.9 Centigrade; Test Date: 20210601; Test Name: pulse rate; Result Unstructured Data: Test Result:59; Comments: bpm; Test Date: 20210601; Test Name: SPO2; Test Result: 97 %
CDC Split Type: JPPFIZER INC2021651581

Write-up: Rash on right hand/over both upper arms; This is a spontaneous report from a contactable physician received from the Agency. Regulatory authority report number is v21111471. A 54-years-old female patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 01Jun2021 at 13:25 (Lot Number: EY0779; Expiration Date: 31Aug2021), at the age of 54 years, as single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient''s body temperature before vaccination was 35.8 degrees Centigrade. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). On 01Jun2021 at 13:35 (10 minutes after the vaccination), the patient experienced rash on right hand/over both upper arms with outcome of recovering. The course of the event was reported as follows: On 01Jun2021 at 13:25, the patient received the second dose of COMIRNATY. At 13:35, rash on the right hand developed. After that, mild rash over both upper arms developed. Blood pressure was 130/67mmHg. Pulse rate was 59 bpm. Body temperature was 35.9 degrees Centigrade. SpO2 was 97%. Blood vessels were secured with saline solution of 500ml. Bypass injection of POLARAMINE 5mg of 1 ampoule (A) and saline solution of 20cc were performed. The symptoms improved gradually. At 14:20, the symptoms disappeared. On 01Jun2021 (the day of the vaccination), the outcome of the event was recovering. The reporting physician classified the event as non-serious and assessed that the event was related to BNT162B2. There was no other possible cause of the event such as any other diseases.


VAERS ID: 1409206 (history)  
Form: Version 2.0  
Age: 80.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY2173 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blister, Blood test, Pruritus, Rash
SMQs:, Severe cutaneous adverse reactions (broad), Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 202106; Test Name: blood had collected; Result Unstructured Data: Test Result:blood had collected
CDC Split Type: JPPFIZER INC2021651710

Write-up: rash; blister; but after a while, it began to itch; This is a spontaneous report from a contactable physician. On 01Jun2021 at 11:30, the 80 years old female patient received the unknown single dose number of COVID-19 mRNA vaccine (BNT162) (COMIRNATY, Lot number: EY2173, Expiration date: 31Aug2021) for COVID-19 immunisation. Medical history and concomitant medications were not reported. There was a patient developed rash all over the body after vaccination, the rash was not like urticaria. In particular, there was no contact history with children, and blisters gradually appeared. Because of the blisters, it seemed that there was no background of new infections such as herpes zoster and herpes. There were soft and small blisters on the whole body, but not in the mouth, so it was not a liquid substance such as severe urticaria, allergy, severe type of chickenpox and blisters, that was to say, there was a patient had rash similar to viral infection. From the appearance, it didn''t itch or pain, but after a while, it began to itch, it had been scratched about half, and scabbed. There were still things like blisters. The patient was an 80 years old female and received the vaccine on 01Jun2021. The patient didn''t notice the rash. The patient made an appointment for the vaccination at 11:30. At 8 p.m. on 01Jun2021, the patient noticed a red thing growing on the upper arm. After the bath, there were small rashes all over the body, except for the face and back. After a period of time, the patient felt blisters appear in the center of the red part on 01Jun2021. After only one day of observation, symptoms began to appear on Tuesday. After a period of time, the patient came here today (physician office visit). About half of the blisters were suspended animation, and many blisters were not residual. However, there were still blisters, and had a tight feeling, it was blisters that seemed not break easily, and not itch or pain. The physician thought it was blisters which was a little harder than chickenpox, but it was obviously blisters. Because there was no blister like SJS in the oral cavity and mucous membrane, feeling it was not urticaria caused by side effect. Now, the patient had been checked, medicine was prescribed, Mino was given and blood had collected in Jun2021. The outcome of the events rash and blister was unknown. No follow-up attempts are possible. No further information expected.; Sender''s Comments: Considering the plausible drug-event temporal association, a contributory role of the suspect product bnt162b2 to the reported events cannot be excluded. Case will be reassessed upon receipt of additional information. 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.


VAERS ID: 1409826 (history)  
Form: Version 2.0  
Age: 68.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Decreased appetite, Diarrhoea, Fatigue, Headache, Muscle spasms, Nausea, Syncope, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Arrhythmia related investigations, signs and symptoms (broad), Pseudomembranous colitis (broad), Dystonia (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Noninfectious diarrhoea (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: TOPZOLE
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210602; Test Name: Temperature; Result Unstructured Data: Test Result:36.6; Comments: celcius
CDC Split Type: ZAPFIZER INC2021687365

Write-up: Vomiting; Severe reaction lasted for 24 Hours leaving the patient very tired for three days; severe nausea; could not eat anything and even water was being rejected; Diarrhoea; fainted; Cramps; Mild headache; This is a spontaneous report from a contactable consumer. A 68-year-old male patient received the first dose of BNT162B2 via an unspecified route of administration on 01Jun2021 at 09:17 at the age of 68-year-old as single dose for COVID-19 immunization. Medical history was not reported. Concomitant medication was included pantoprazole sodium sesquihydrate (TOPZOLE). On 01Jun2021 at 23:00, the patient experienced fainted (medically significant) and cramps. On an unspecified date, the patient experienced vomiting. On 01Jun2021 at 20:00, the patient experienced mild headache. On 02Jun2021, the patient experienced diarrhea. On an unspecified date, the patient experienced severe reaction lasted for 24 hours leaving the patient very tired for three days. And on 02Jun2021, the patient also experienced severe nausea and could not eat anything and even water was being rejected. On 02Jun2021, the patient''s body temperature was 36.6 celcius. Therapeutic measures were taken as a results of mild headache. The outcome of vomiting, tiredness, cramps, faint, diarrhoea, nausea and appetite lost were recovering and the outcome of headache was recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1410583 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-30
Onset:2021-06-01
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Haematuria, Ultrasound scan
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Tubulointerstitial diseases (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: ultrasound; Result Unstructured Data: Test Result:showed no signs of stones or issues along with the; Comments: showed no signs of stones or issues along with the fact that (a small kidney stone)
CDC Split Type: CAPFIZER INC2021656432

Write-up: gross hematuria with a lot of blood while urinating 3 times that evening; This is a spontaneous report received via Regulatory Authority from a contactable consumer (patient). An adolescent female patient of unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 30May2021 (Batch/Lot number was not reported) as unknown, single for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 01Jun2021 at 21:00, the patient experienced gross hematuria with a lot of blood while urinating 3 times that evening. Patient experienced no pain, fever, headache, or other. In the following day, patient had an ultrasound and was checked by a Doctor. They did not correlate to the vaccination and stated could have been a small kidney stone although the ultrasound showed no signs of stones or issues along with the fact that Patient experienced no pain during this event. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No list of any other medications the patient received within 2 weeks of vaccination. The adverse events result in following: Doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of event was unknown. Information on the lot/batch number has been requested.


VAERS ID: 1410587 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-31
Onset:2021-06-01
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Amylase, Lipase, Pancreatitis
SMQs:, Acute pancreatitis (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none.
Allergies:
Diagnostic Lab Data: Test Date: 20210601; Test Name: amylase; Result Unstructured Data: Test Result: elevated; Comments: Amylase (Unknown): elevated. Within 12 hours, sever abdomen pain with lipase and amylase elevated: pancreatitis.; Test Date: 20210601; Test Name: lipase; Result Unstructured Data: Test Result: elevated; Comments: Lipase (Unknown): elevated. Within 12 hours, sever abdomen pain with lipase and amylase elevated: pancreatitis.
CDC Split Type: CAPFIZER INC2021664871

Write-up: within 12 hours, sever abd pain with lipase and amylase elevated: pancreatitis; This is a spontaneous report received from a contactable physician. A 36 years old Male patient received BNT162B2 on 31May2021 (at age of 36 years old) at single dose for COVID-19 immunisation. Medical history and concomitant medications were none. No past drug history. No other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. Within 12 hours (01Jun2021), severe abdominal pain with lipase and amylase elevated: pancreatitis. Patient was hospitalized for two days. No treatment received for the event. The outcome of the event was recovering. The event result in Emergency room/department or urgent care. Prior to vaccination, the patient was not diagnosed with COVID19. Since the vaccination, the patient had not been tested for COVID19. Information about batch/lot number had been request.; Sender''s Comments: Based on limited information provided, the event pancreatitis more likely represents an intercurrent illness which is unrelated to BNT162B2. The case will be reassessed once more information become 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.


VAERS ID: 1410606 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-06-01
Submitted: 0000-00-00
Entered: 2021-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Drug ineffective, Feeling abnormal, Pyrexia, SARS-CoV-2 test, SARS-CoV-2 test positive
SMQs:, Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210609; Test Name: covid; Result Unstructured Data: Test Result:positive
CDC Split Type: COPFIZER INC2021677851

Write-up: This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received second dose of BNT162B2 (Solution for injection) via an unspecified route of administration on Jun2021 (reported as the week before the time of reporting, Batch/Lot number was not reported) as single dose, first dose via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for Covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient informed that he received the first dose without effects, and commented that the week before the time of reporting (Jun2021) and from then he started to feel bad and on the day of reporting (09Jun2021) he was positive for Covid, he commented that he had fever and asked for the reasons why it could have happened. Outcome of the event fever was not recovered, whereas other events was unknown. Information on the lot/batch number has been requested.


VAERS ID: 1410660 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Nausea, Syncope, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021663457

Write-up: syncope; chills; vomiting; nausea; This is a spontaneous report from a non-contactable consumer (patient). A 48-years-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 01Jun2021 (Batch/Lot number was not reported) as UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient experienced syncope 13 hours after vaccination, chills, vomiting, nausea, all on an unspecified date in Jun2021 with outcome of unknown. No follow-up attempts are possible, information about lot/batch number cannot be obtained.


VAERS ID: 1411232 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK LA / -

Administered by: Other       Purchased by: ?
Symptoms: Fibrin D dimer, Fibrin D dimer increased, Pain in extremity, Phlebitis
SMQs:, Haemorrhage laboratory terms (broad), Thrombophlebitis (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anemia
Allergies:
Diagnostic Lab Data: Test Date: 20210601; Test Name: fibrin d dimer; Result Unstructured Data: Test Result:increased
CDC Split Type: FRPFIZER INC2021664492

Write-up: Fibrin D dimer increased; intense and acute pain in calf leading to phlebitis suspicion; intense and acute pain in calf leading to phlebitis suspicion; This is a spontaneous report from a contactable pharmacist (patient). A 37-year-old female patient received bnt162b2 (COMIRNATY, Solution for injection), via an unspecified route of administration, administered in left arm at the age of 37-year-old on 01Jun2021 10:45 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included anemia. The patient was not pregnant. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were no concomitant medications. The patient experienced fibrin d dimer increased (hospitalization) on 01Jun2021 16:30, intense and acute pain in calf leading to phlebitis suspicion (hospitalization) on 01Jun2021 16:30. The patient was hospitalized for events for 1 days. Since the vaccination, the patient has not been tested for COVID-19. The patient underwent lab tests and procedures which included fibrin d dimer: increased on 01Jun2021. Therapeutic measures were taken as a result of events (rivaroxaban (XARELTO)). The outcome of events was recovering. Information on the lot/batch number has been requested.; Sender''s Comments: Based on the available information and known product profile, the causal relationship between the reported events and the use of bnt162b2 cannot be fully excluded. There is limited information thus precluding a more meaningful assessment. The case will be assessed further upon receipt of additional information. 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.


VAERS ID: 1411252 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-21
Onset:2021-06-01
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET8885 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Herpes zoster
SMQs:, Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021657196

Write-up: Shingles; This is a spontaneous report from a contactable consumer or other non-HCP. This is a report received from the Regulatory Agency (RA). Regulatory authority report number GB-MHRA-EYC 00252388, Safety Report Unique Identifier GB-MHRA-EYC 00252388. A 38-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH m-RNA COVID-19 VACCINE,Formulation: Solution for injection, Lot Number: Et8885), via an unspecified route on 21May2021 as 1ST DOSE, SINGLE DOSE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced shingles (hospitalization) on 01Jun2021. The outcome of the event was not recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1411326 (history)  
Form: Version 2.0  
Age: 44.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-08
Onset:2021-06-01
   Days after vaccination:85
Submitted: 0000-00-00
Entered: 2021-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: IRBESARTAN; BISOPROLOL
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210601; Test Name: Nasal Swab; Result Unstructured Data: Test Result:Positive
CDC Split Type: CRPFIZER INC2021672039

Write-up: covid test post vaccination positive; covid test post vaccination positive; This is a spontaneous report from a contactable physician (patient) by regulatory authority. A 44-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) solution for injection intramuscular, first dose on 08Mar2021 at 14:30 in the left arm (lot unknown) and second dose on 29Mar2021 at 14:30 in the left arm (lot unknown) (at the age of 44-years-old) as a single dose for COVID-19 immunisation. The facility where the most recent COVID-19 vaccine was administered was hospital. Medical history was not reported. Concomitant medications included irbesartan and bisoprolol. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had been tested for COVID-19, Nasal Swab and was positive on 01Jun2021. The outcome of the event was unknown. Information on the lot/batch number has been requested.; Sender''s Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Vaccination failure and COVID-19 cannot be totally excluded. The case will be reassessed if additional information becomes available.


VAERS ID: 1411375 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Fatigue, Periarthritis, Vaccination site pain
SMQs:, Arthritis (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: RIGEVIDON [ETHINYLESTRADIOL;LEVONORGESTREL]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Contraception; Comments: .
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021655461

Write-up: Frozen shoulder; Vaccination site pain / site of injection was slightly sore; Tiredness; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202106021241038380-DVF03. Safety Report Unique Identifier GB-MHRA-ADR 25404817. A 32-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm on 01Jun2021 (Batch/Lot number was not reported) at the age of 32 years old, as a single dose for Covid-19 immunisation. Medical history included contraception. Patient has not had symptoms associated with COVID-19; has not had a COVID-19 test. Unsure if patient was enrolled in clinical trial. Patient was not pregnant at the time of vaccination. Patient was not currently breastfeeding. Concomitant medication included ethinylestradiol, levonorgestrel (RIGEVIDON [ETHINYLESTRADIOL;LEVONORGESTREL]) taken for contraception, start and stop date were not reported. The patient experienced frozen shoulder, vaccination site pain, and tiredness on 01Jun2021. The patient reported that the site of injection (arm) was slightly sore straight after the injection, as expected. However, a few hours later the pain (at injection site) increased significantly and patient was not able to rotate or lift her arm. She has not engaged in any strenuous physical activity before or after the vaccination. She stated that taking paracetamol did not improve the ability to move her arm. The severity of this will depend on how long it lasts, as currently she was not able to perform any tasks with affected arm. The events were reported as medically significant and caused disability. Patient has not tested positive for COVID-19 since having the vaccine. Outcome of the event frozen shoulder was not recovered; unknown for vaccination site pain; and patient was recovering from tiredness. No follow-up attempts are possible; Information about lot/batch number cannot be obtained.


VAERS ID: 1411379 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET8885 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Fatigue, Headache, Nausea, Pain in extremity
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021649650

Write-up: Tiredness; Painful arm; Headache; Nausea; This is a spontaneous report from a contactable consumer received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202106021351089470-KADC3; Safety Report Unique Identifier is GB-MHRA-ADR 25405544. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: ET8885), via an unspecified route of administration on 01Jun2021 (unknown age at time of vaccination) as single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced tiredness, painful arm, headache, and nausea on 01Jun2021. Events were assessed as serious with criteria of Other medically important condition. Patient has not tested positive for COVID-19 since having the vaccine. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient is not enrolled in clinical trial. The outcome of the events was not recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1411392 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER7812 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cough, Pain, Pyrexia, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210503; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021649056

Write-up: Cough; Fever; General body pain; This is a spontaneous report from a contactable consumer. This is a report received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202106021902532270-UM5NL, Safety Report Unique Identifier GB-MHRA-ADR 25407989. A 38-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 01Jun2021 (lot number: ER7812), at the age of 38 years) as the 2nd dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient has not tested positive for COVID-19 since having the vaccine. The patient experienced fever and general body pain on 01Jun2021 and cough on 02Jun2021. The patient negative COVID-19 test on 03May2021. Patient took paracetamol but it did not help with the fever. The events were considered medically significant. The patient has not recovered from the events. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1411397 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-29
Onset:2021-06-01
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Menstruation delayed, SARS-CoV-2 test
SMQs:, Fertility disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CITALOPRAM
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19 (unsure when symptoms started nor stopped)
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021649140

Write-up: Delayed period; This is a spontaneous report from a contactable consumer. This is a report received from the regulatory authority, report number is GB-MHRA-WEBCOVID-202106022321247210-6CGOC, Safety Report Unique Identifier GB-MHRA-ADR 25408934. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on as 1st dose, single for COVID-19 immunization. Patient is not enrolled in clinical trial. Medical history included suspected COVID-19, unsure when symptoms started nor stopped. Concomitant medication included citalopram. Patient has not tested positive for COVID-19 since having the vaccine. The patient experienced delayed period, medically significant on 01Jun2021. The patient had negative COVID-19 test on an unspecified date. The patient has not recovered from the event. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1411406 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Hot flush, Maternal exposure during pregnancy, SARS-CoV-2 test, Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FOLIC ACID
Current Illness: Pregnancy
Preexisting Conditions: Medical History/Concurrent Conditions: Folic acid supplementation; Lactation decreased
Allergies:
Diagnostic Lab Data: Test Date: 20210601; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021655390

Write-up: Hot flush/ Hot flushes; Vomiting; Maternal exposure during pregnancy/ patient was exposed to the medicine at first trimester (1-12 weeks); This is a spontaneous report from a contactable consumer received from the Regulatory Agency (UK-MHRA); the Regulatory Authority report number is GB-MHRA-WEBCOVID-202106030830248890-6OIFH and the Safety Report Unique Identifier is GB-MHRA-ADR 25410112. A 31-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 01Jun2021 (batch/lot number was not reported) at 31 years old as 1ST DOSE, SINGLE for COVID-19 immunization. The patient''s medical history included lactation decreased and folic acid supplementation, both from an unknown date. The patient was not enrolled in clinical trial. Patient is currently pregnant and not breastfeeding. Date of last menstrual period was unknown. Patient has not had symptoms associated with COVID-19. Concomitant medication included folic acid (FOLIC ACID) taken for folic acid supplementation, start and stop date were not reported. The patient experienced maternal exposure during pregnancy on 01Jun2021. It was reported that the patient was exposed to the medicine at first trimester (1-12 weeks). The patient also experienced hot flush/hot flushes and then vomiting on 02Jun2021. The patient has not recovered from the events hot flush/hot flushes and then vomiting. Outcome of "maternal exposure during pregnancy/ patient was exposed to the medicine at first trimester (1-12 weeks)" was unknown. The events were reported as medically significant. The patient has not tested positive for COVID-19 since having the vaccine; patient tested no - negative for COVID-19 virus test on 01Jun2021. No follow-up attempts are possible; information about the batch/lot number cannot be obtained.


VAERS ID: 1411412 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-31
Onset:2021-06-01
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW3143 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Creutzfeldt-Jakob disease, Fatigue, Feeling cold, Headache, Lymphadenopathy, Malaise
SMQs:, Dementia (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021655496

Write-up: Swollen lymph nodes/ day 2 onward slightly enlarged axillary lymph nodes; tiredness; sporadic headache/ Creutzfeldt-Jakob disease; Headache; Feeling cold; Malaise; This is a spontaneous report from a contactable consumer received from the regulatory authority report number is GB-MHRA-WEBCOVID-202106030902134560-EVTYL, Safety Report Unique Identifier GB-MHRA-ADR 25410639. A 26-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 31May2021 (Lot Number: EW3143) as 1ST DOSE, SINGLE for COVID-19 immunisation. Medical history included suspected COVID-19 from 18Mar2020 to 01Apr2020. Not had a COVID-19 test and patient was not enrolled in clinical trial. Concomitant medications were not reported. On 01Jun2021, day 1 after vaccination, the patient experienced general malaise and feeling of cold, headache, sporadic headache/Creutzfeldt-Jakob disease, tiredness. Symptoms were short-lasting and responding to treatment with paracetamol. On 02Jun2021, patient experienced swollen lymph nodes/ day 2 onward slightly enlarged axillary lymph nodes, single sided, side of injection, palpable, not painful. The events were considered serious, medically significant. Patient has not tested positive for COVID-19 since having the vaccine. The outcome of the event tiredness, sporadic headache/Creutzfeldt-Jakob disease, swollen lymph nodes/ day 2 onward slightly enlarged axillary lymph nodes was recovering; feeling cold and malaise was recovered on 01Jun2021, while headache was recovered on 02Jun2021. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1411413 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-28
Onset:2021-06-01
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW2245 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dizziness postural, Fatigue, Feeling abnormal, Gait disturbance, Head injury, Loss of consciousness, SARS-CoV-2 test, Somnolence, Vertigo
SMQs:, Torsade de pointes/QT prolongation (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Vestibular disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210603; Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC2021655614

Write-up: head injury; unconsciousness; spaced out; Vertigo; Drowsiness; Dizziness/dizziness when standing or walking; unable to walk in straight line; Tiredness; This is a spontaneous report from a contactable consumer (patient) received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202106030906157570-YPDWA, Safety Report Unique Identifier GB-MHRA-ADR 25410766. A 32-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number: EW2245) via an unspecified route of administration on 28May2021 at single dose for COVID-19 immunization. Medical history was not reported. Patient had not had symptoms associated with COVID-19, was not enrolled in clinical trial. The patient''s concomitant medications were not reported. The patient experienced unconsciousness on an unspecified date with outcome of recovering; spaced out on an unspecified date with outcome of recovering; vertigo on 02Jun2021 with outcome of not recovered; tiredness on 01Jun2021 with outcome of not recovered; drowsiness on 02Jun2021 with outcome of not recovered; dizziness on 02Jun2021 with outcome of not recovered. It was reported that on 01Jun2021 felt tiredness all day similar feeling to hangover. Woke on 02Jun2021 with bad vertigo, which took several hours to fully go, remainder of the day was dizziness when standing or walking, unable to walk in straight line. Only comparison he could make was the feeling of post unconsciousness after head injury. Spaced out feeling and tiredness. Woke on 03Jun2021 with less vertigo symptoms but dizziness and spaced out feeling still present. The patient underwent lab tests and procedures which included COVID-19 virus test was negative on 03Jun2021. Outcome of the other events was unknown. The events were reported as serious and seriousness criteria was provided as other medically important condition. Patient has not tested positive for COVID-19 since having the vaccine. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1411420 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-27
Onset:2021-06-01
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET8885 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Pain in extremity, SARS-CoV-2 test
SMQs:, Tendinopathies and ligament disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021655683

Write-up: Leg pain; This is a spontaneous report from a contactable consumer. This is a report received from the MHRA. Regulatory authority report number GB-MHRA-WEBCOVID-202106030922300910-AY7Q8, Safety Report Unique Identifier GB-MHRA-ADR 25410813. A 37-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: Et8885), via an unspecified route of administration on 27May2021 at single dose for covid-19 immunization. Medical history and concomitant medications were not reported. Unsure if patient has had symptoms associated with COVID-19. Patient was not enrolled in clinical trial. The patient experienced leg pain on 01Jun2021. The event was serious for being medical significant. The patient underwent lab tests included COVID-19 virus test: negative on unknown date (reported as No - Negative COVID-19 test). Patient has not tested positive for COVID-19 since having the vaccine. The outcome of event was not recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1411421 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-30
Onset:2021-06-01
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY5456 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Pain in extremity, Peripheral swelling, SARS-CoV-2 test, Vaccination site erythema, Vaccination site swelling
SMQs:, Cardiac failure (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Tendinopathies and ligament disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021655568

Write-up: significant swelling (vaccination site swelling)/swelling and redness from injection site; redness from injection site; pain in arm and fingers; swelling arm; This is a spontaneous report from a contactable consumer received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202106030930239370-JUKM4. A 32-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via unspecified route of administration on 30May2021 (batch/lot number EY5456 and expiry date unknown) as 1st dose, single for covid-19 immunization. Medical history included suppressed lactation. The patient had no known allergies, has not had symptoms associated with COVID-19, was not enrolled in clinical trial, was not currently breastfeeding. The patient''s concomitant medications were not reported. On an unspecified date, the patient experienced significant swelling (vaccination site swelling). On 01Jun2021, the patient experienced swelling arm. The reporter informed that the patient experienced swelling and redness from injection site, pain in arm and fingers, significant swelling. The events were reported serious as other medically important condition. The patient underwent lab tests and procedures which included COVID-19 virus test: no - negative covid-19 test on unspecified date. The patient has not tested positive for COVID-19 since having the vaccine. The outcome of the event swelling arm was not recovered, while unknown for the rest of the events. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1411429 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET8885 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Grip strength decreased, Muscular weakness, Peripheral swelling, SARS-CoV-2 test, Seizure, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Cardiac failure (broad), Angioedema (broad), Peripheral neuropathy (broad), Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20210110; Test Name: COVID-19 virus test; Test Result: Positive ; Comments: Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC2021655676

Write-up: Swollen thumb/ Swelling of hands; difficult to grip due to reduced grip strength and arm weakness; difficult to grip due to reduced grip strength and arm weakness; Fainting; convulsions; This is a spontaneous report from a contactable Other Health Professional (HCP). This is a report received from the Regulatory Agency (RA). Regulatory authority report number is GB-MHRA-WEBCOVID-202106031012020670-GWN1K, Safety Report Unique Identifier GB-MHRA-ADR 25411247. A 31-year-old male patient received BNT162B2 (COVID-19 MRNA VACCINE BIONTECH, Lot Number: ET8885), the first dose via an unspecified route of administration at single dose on 01Jun2021 for COVID-19 immunization. Medical history included suspected COVID-19 from 10Jan2021 to 24Jan2021. Patient was not enrolled in clinical trial. The patient''s concomitant medications were not reported. The patient experienced fainting on 01Jun2021, swollen thumb/ swelling of hands on 02Jun2021. Fainting episodes twice with convulsions. Required oxygen treatment to assist recovery. Swollen left hand and thumb the next day which made it difficult to grip due to reduced grip strength and arm weakness. Patient had not tested positive for COVID-19 since having the vaccine. The patient underwent lab tests and procedures which included COVID-19 virus test: positive (Yes - Positive COVID-19 test) on 10Jan2021. The outcome of the events fainting, convulsions was recovered on 01Jun2021, for the event swollen thumb/ swelling of hands was recovered on 03Jun2021, while other events were unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1411445 (history)  
Form: Version 2.0  
Age: 22.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET8885 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cough, Headache, Pyrexia, Rhinorrhoea, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021655405

Write-up: Fever; Cough; Runny nose; Headache; This is a spontaneous report. A 22-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 01Jun2021 (Lot Number: ET8885) as 1st dose, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Patient is not enrolled in clinical trial. The patient experienced headache on 01Jun2021 with outcome of recovering, fever on 02Jun2021 with outcome of recovered on 03Jun2021, cough on 02Jun2021 with outcome of not recovered, and runny nose on 02Jun2021 with outcome of not recovered. The events were assessed as serious (medically significant) by the health authority. The patient underwent lab test which included COVID-19 virus test: No - Negative COVID-19 test on an unspecified date. Patient has not tested positive for COVID-19 since having the vaccine. No follow up attempts are possible. No further information is expected.


VAERS ID: 1411449 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-30
Onset:2021-06-01
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal distension, Dysmenorrhoea, Fatigue, Hormone level abnormal, Hypoaesthesia, Mood swings, Muscle spasms, Nausea, Pain in extremity, SARS-CoV-2 test, Thalassaemia minor
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Dementia (broad), Congenital, familial and genetic disorders (narrow), Dystonia (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Depression (excl suicide and self injury) (broad), Tendinopathies and ligament disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: DESOGESTREL; PARACETAMOL; XYZAL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Coeliac disease; Lactation decreased; Urticaria
Allergies:
Diagnostic Lab Data: Test Date: 20210528; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021655594

Write-up: thalassemia trait; nausea; leg pain; numbness; bloating; cramps; tiredness; mood swings; Period pains; hormonal imbalance; This is a spontaneous report from a contactable consumer received from the regulatory authority (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202106031226376490-HCNHE, Safety Report Unique Identifier GB-MHRA-ADR 25412678. A 35-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 30May2021 (Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included coeliac disease, suppressed lactation, a very bad episode of urticaria many years ago. Patient has not had symptoms associated with COVID-19. Patient is not enrolled in clinical trial. Patient is not pregnant, is not currently breastfeeding. Concomitant medications included desogestrel taken at 75 mg for dysmenorrhea from Sep2020 to an unspecified stop date; paracetamol taken for headache, start and stop date were not reported; levocetirizine dihydrochloride (XYZAL) taken for histamine level, start and stop date were not reported. The patient previously took ketotifen. 24 hours after the vaccination, she started feeling uncomfortable, experienced some of the side effects of the vaccine but on 01Jun2021, she had a little spotting and 02Jun2021 was like her period was back again (day n.25 on her pill blister): very little flow, but cramps, leg pain, numbness, tiredness, bloating, nausea, mood swings (no headache likely). It''s like she had an hormonal imbalance. The patient experienced period pains on 01Jun2021, thalassemia trait, switched from a pill to another brand one last month, nausea, hormonal imbalance on 01Jun2021, leg pain, numbness, bloating, cramps, tiredness, mood swings (no headache likely). All events were medically significant. The patient underwent lab tests and procedures which included COVID-19 virus test on 28May2021: No - Negative COVID-19 test. Patient has not tested positive for COVID-19 since having the vaccine. Outcome of the events was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1411479 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-31
Onset:2021-06-01
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH PW3143 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Chest pain, Inflammation, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Arthritis (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CLENIL MODULITE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma; Immunodeficiency (Taking other treatments or medicines, not listed above, known to lower the immune response and i...); Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021655724

Write-up: Chest pain; Pins and needles/ prickling sensations; Pain seemed concentrated on left side of chest, and into left shoulder (got vaccine in left arm?); inflammation caused by the vaccine; This is a spontaneous report from a contactable consumer. This is a report received from the RA. Regulatory authority report number GB-MHRA-WEBCOVID-202106031534560260-MMKAK, Safety Report Unique Identifier GB-MHRA-ADR 25414166. A 30-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 31May2021 (Lot Number: PW3143) as single dose for COVID-19 immunisation. Medical history included lactation decreased, immunodeficiency (Taking other treatments or medicines, not listed above, known to lower the immune response and I......), asthma. Patient had not had symptoms associated with COVID-19 and had not a COVID-19 test. Patient was not pregnant or was not currently breastfeeding. Concomitant medications included beclometasone dipropionate (CLENIL MODULITE) taken for asthma. The patient experienced pins and needles on 01Jun2021 and chest pain on 03Jun2021. Patient had not tested positive for COVID-19 since having the vaccine. The outcome of pins and needles and chest pain was not recovered, while for remains event was unknown. The clinical course was reported as follows: Pins and needles and prickling sensations started the day after vaccine, on 01Jun2021. They began in my hands, feet and legs. The next day they had spread to my whole body, including scalp, face, arms, hands, legs and feet. Woke up with chest pain on the morning of the 03Jun2021. Sharp pain especially when breathing in deeply. Pain seemed concentrated on left side of chest, and into left shoulder (got vaccine in left arm?). The sharp pain also happens when I move into certain positions. Suspect Reactions: Please provide details of any relevant investigations or tests conducted: Spoke to my GP on 3rd June. He said chest pain and pins and needles could be due to inflammation caused by the vaccine. Told to call (Phone number) if worsening, but to rest for a few days and take Paracetamol. If not better in a week or so told to make another appointment. No follow-up attempts are possible. No further information expected.


VAERS ID: 1411494 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Heart rate, Heart rate irregular, Illness
SMQs:, Anticholinergic syndrome (broad), Cardiac arrhythmia terms, nonspecific (narrow), Vestibular disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Pregnancy
Allergies:
Diagnostic Lab Data: Test Date: 20210603; Test Name: heartbeats; Result Unstructured Data: Test Result:irregular
CDC Split Type: GBPFIZER INC2021655494

Write-up: Heartbeats irregular; Felt faint; Sickness; This is a spontaneous report from a contactable consumer received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202106031701284650-QA3UG, Safety Report Unique Identifier: GB-MHRA-ADR 25414859. A 36-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 01Jun2021 (lot number: not known) at 1st dose, single for COVID-19 immunisation. Medical history included pregnancy. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient is not enrolled in clinical trial. The patient''s concomitant medications were not reported. The patient experienced sickness on 01Jun2021; and heartbeats irregular and felt faint on 03Jun2021. Patient has not tested positive for COVID-19 since having the vaccine. The outcome of all the events was not recovered. Regulatory authority assessed the events as serious for being medically significant. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1411499 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-01
Onset:2021-06-01
   Days after vaccination:31
Submitted: 0000-00-00
Entered: 2021-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Heavy menstrual bleeding, Menstrual disorder, SARS-CoV-2 test
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: IMPLANON
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021655268

Write-up: Heavy periods/very heavy menstrual bleeding; very heavy menstrual bleeding with large clots; This is a spontaneous report from a contactable consumer received from the regulatory authority, report number is GB-MHRA-WEBCOVID-202106031742023050-K43NL, Safety Report Unique Identifier GB-MHRA-ADR 25415047. A 42-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in May2021 (lot number and expiry date: unknown) unknown, single, for COVID-19 immunisation. Medical history included lactation decreased. Patient has not had symptoms associated with COVID-19. Patient is not enrolled in clinical trial. Patient is not pregnant. Patient is not currently breastfeeding. Concomitant medication included etonogestrel (IMPLANON) taken for contraception. On 01Jun2021, the patient experienced heavy periods/ very heavy menstrual bleeding with large clots. The events were considered serious due to other medically important condition. The patient underwent lab tests and procedures which included COVID-19 virus test: no-negative on unspecified date. Patient has not tested positive for COVID-19 since having the vaccine. Outcome of the events was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1411504 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET8885 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Blood pressure measurement, Dizziness, Feeling abnormal, Headache, Heart rate, Heart rate decreased, Hypotension, Seizure, Thirst, Vaccination site pain
SMQs:, Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Vestibular disorders (broad), Generalised convulsive seizures following immunisation (narrow), Arthritis (broad), Hypoglycaemia (broad), Dehydration (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210601; Test Name: blood pressure; Result Unstructured Data: Test Result:low; Test Date: 20210601; Test Name: Heart rate; Result Unstructured Data: Test Result:low
CDC Split Type: GBPFIZER INC2021655710

Write-up: headache; woozy/spaced out; woozy/spaced out; Heart rate low; Low blood pressure; felt thirsty; sat up for 15minutes after this; Injection site pain; Joint ache; This is a spontaneous report from a contactable consumer received from the regulatory authority report number is GB-MHRA-WEBCOVID-202106031807054600-EXU36. Safety Report Unique Identifier GB-MHRA-ADR 25415670. A 28-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration at 1ST DOSE, SINGLE on 01Jun2021 (Batch/Lot Number: ET8885) (at age of 28-year-old) for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. No medication. Patient has not had symptoms associated with COVID-19. Patient is not enrolled in clinical trial. The patient experienced headache (medically significant) on 01Jun2021 with outcome of unknown, woozy/spaced out (medically significant) on 01Jun2021 with outcome of unknown, heart rate low (medically significant) on 01Jun2021 with outcome of recovered on 01Jun2021, low blood pressure (medically significant) on 01Jun2021 with outcome of recovered on 01Jun2021, felt thirsty (medically significant) on 01Jun2021 with outcome of unknown, sat up for 15minutes after this (medically significant) on 01Jun2021 with outcome of recovered in Jun2021, injection site pain (medically significant) on 01Jun2021 with outcome of recovered on 03Jun2021, joint ache (medically significant) on 01Jun2021 with outcome of recovering. The clinical course reported 15minutes after receiving vaccine, felt a headache and woozy/spaced out. Nurses monitored heart rate and blood pressure, both were found to be low. Had to lie down with facemask removed and elevate feet for 30minutes in order to maintain consciousness. Water was supplied as felt thirsty. Sat up for 15minutes after this, gradually feeling better. After this walked slowly to the car with my partner. No issues since. Patient has not tested positive for COVID-19 since having the vaccine. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1411559 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-29
Onset:2021-06-01
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW3143 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Back pain, Chills, Fatigue, Headache, Menstrual disorder, Muscle spasms, Myalgia, Nausea, Pyrexia, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Dystonia (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Fatigue
Allergies:
Diagnostic Lab Data: Test Date: 20201221; Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC2021655624

Write-up: i have started to recover and feel almost recovered only today; Muscle spasm; Chills; Fever; Back pain; Muscle ache; Joint pain; Fatigue/Tiredness; Nausea; Headache; This is a spontaneous report from a contactable consumer (patient) received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202106031823516290-FYHKR. Safety Report Unique Identifier GB-MHRA-ADR 25416132. A 32-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number: EW3143), via an unspecified route of administration on 29May2021 at single dose for COVID-19 immunisation. Medical history included fatigue. Patient had not had symptoms associated with COVID-19, was not enrolled in clinical trial. Concomitant medications were unknown. The patient experienced menstruation abnormal (as reported, described as "i have started to recover and feel almost recovered only today") on an unspecified date with outcome of recovering; fever on 01Jun2021 with outcome of recovered on 02Jun2021; joint pain on 01Jun2021 with outcome of recovered on 03Jun2021; back pain on 01Jun2021 with outcome of recovering; nausea on 01Jun2021 with outcome of recovered on 03Jun2021; chills on 01Jun2021 with outcome of recovered on 03Jun2021; muscle ache on 01Jun2021 with outcome of recovered on 03Jun2021; muscle spasm on 02Jun2021 with outcome of recovered on 02Jun2021; fatigue/tiredness on 01Jun2021 with outcome of recovering; headache on 01Jun2021 with outcome of recovered on 03Jun2021. The patient reported that he received the vaccine on 29May2021 Saturday late afternoon. He had no side effects until Tuesday morning, almost 3 days after the injection. It started with joint pains on both of his knees and fatigue on Tuesday morning (01Jun2021). Later in the day, he started having nausea. By 11pm of the same day, he started having chills, eventually fever until about 3 am in the morning. Joint pain, back pain, nausea were still consistent whilst having fever. Fever stopped around 3am, however, rest of the side effects were still consistent. He could only fall asleep after taking paracetamol. Pain was consistent the next day. He was referred to an ED by emergency service. Feeling all the above side effects (except fever by this point), increased tiredness, and fatigue. At the hospital, he was prescribed naproxen 250mg to ease the unbearable joint pain on his knees. He had started to recover and feel almost recovered only today, Thursday, 03Jun2021. The patient underwent lab tests and procedures which included COVID-19 virus test was negative on 21Dec2020. The events were reported as serious and seriousness criteria was provided as other medically important condition. Patient has not tested positive for COVID-19 since having the vaccine No follow-up attempts are possible. No further information is expected.


VAERS ID: 1411562 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-06-03
Onset:2021-06-01
Submitted: 0000-00-00
Entered: 2021-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET8885/V1193 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: SARS-CoV-2 test, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021655296

Write-up: Fainting; This is a spontaneous report from a contactable pharmacist. This is a report received from the Regulatory Authority. Regulatory authority report number is GB-MHRA-WEBCOVID-202106031838417900-ADKFX, Safety Report Unique Identifier GB-MHRA-ADR 25415483. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: ET8885/V1193), via an unspecified route of administration on 03Jun2021 at first dose, single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19 and was not enrolled in clinical trial. The patient experienced fainting on Jun2021. The event was reported as non-serious. The patient underwent COVID-19 virus test on an unspecified date with the following result: No - Negative COVID-19 test. The patient recovered from the event fainting on Jun2021. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1411589 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-05-28
Onset:2021-06-01
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW3143 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Ageusia, Anosmia, Body temperature, COVID-19, Cold sweat, Diarrhoea, Headache, Myalgia, Pyrexia, SARS-CoV-2 test, Vomiting
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Taste and smell disorders (narrow), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Noninfectious diarrhoea (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210602; Test Name: temperature; Result Unstructured Data: Test Result:high; Test Date: 20210602; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC2021655364

Write-up: vomited; positive COVID-19 test; High temperature; Diarrhea; Loss of smell; Loss of taste; Headache; Muscle ache; Cold sweat; This is a spontaneous report from a contactable other healthcare professional. This is a report received from the Regulatory Agency (RA). Regulatory authority report number is GB-MHRA-WEBCOVID-202106032217139730-2HPPX. Safety Report Unique Identifier is GB-MHRA-ADR 25417213. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 28May2021 (Lot Number: EW3143) as 1st dose, single for COVID-19 immunisation. Medical history was not reported. Patient was not enrolled in clinical trial. Concomitant medications were not reported. The patient experienced positive COVID-19 test on 02Jun2021 with outcome of not recovered, vomited on an unspecified date with outcome of unknown, cold sweat on 01Jun2021 with outcome of not recovered, high temperature on 02Jun2021 with outcome of recovering, diarrhea on 02Jun2021 with outcome of not recovered, loss of smell on 02Jun2021 with outcome of not recovered, loss of taste on 02Jun2021 with outcome of not recovered, headache on 02Jun2021 with outcome of not recovered, and muscle ache on 01Jun2021 with outcome of not recovered. It was reported that patient was suspected COVID-19 from 01Jun2021 and ongoing. The patient underwent lab test which included COVID-19 virus test: yes - positive COVID-19 test on 02Jun2021. Additional information: After first dose of vaccine, no side effects happened until 2 days later. Patient associated the symptoms to side effects of vaccine but had a PCR test which confirmed patient had COVID19. Patient''s family got tested, all came back negative. The events were assessed as serious (medically significant) by the health authority. No follow-up attempts are possible. No further information expected.


VAERS ID: 1411596 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-01
Submitted: 0000-00-00
Entered: 2021-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Lymph node pain, Lymphadenopathy, Muscular weakness, Pain in extremity
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021655729

Write-up: Swollen lymph nodes; pain under my left arm/ lymph nodes; pain under my left arm/ lymph nodes; my left arm is weak all down it to my fingers; This is a spontaneous report from a contactable consumer (patient) received from the Agency Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202106032249578040-MUYLT. Safety Report Unique Identifier GB-MHRA-ADR 25417336. A 46-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at single dose on 02Jun2021 (at the age of 46-year-old) (Batch/Lot number was not reported) for COVID-19 immunisation. Medical history included lactation decreased. Patient had not had symptoms associated with COVID-19. Patient had not had a COVID-19 test. Patient was not enrolled in clinical trial. Patient was not pregnant. Patient was not currently breastfeeding. The patient''s concomitant medications were not reported. The patient experienced swollen lymph nodes on 02Jun2021. The patient stated that in addition to pain under her left arm/lymph nodes, her left arm was weak all down it to her fingers in Jun2021. Patient had not tested positive for COVID-19 since having the vaccine. The outcome of the event swollen lymph nodes was not recovered. The outcome of the other events was unknown. The report was reported as serious with the criteria of medically important condition. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1411604 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET8885 / 1 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Hypoaesthesia, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Clinical trial participant; Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021655585

Write-up: Numbness; Pins and needles; This is a spontaneous report from a contactable consumer (patient) received from the Regulatory Authority (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202106040010359980-X9LH4. Safety Report Unique Identifier GB-MHRA-ADR 25417445. A 31-year-old female patient (not pregnant, not currently breastfeeding; age at vaccination: 31-year-old) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: ET8885) via an unspecified route of administration in the left arm on 01Jun2021 as first dose, single for COVID-19 immunisation. Medical history included suppressed lactation and a clinical trial participant. Patient has not had symptoms associated with COVID-19, not had a COVID-19 test. The patient''s concomitant medications were not reported. On 01Jun2021, the patient experienced numbness around 3 episodes and they lasted around 20 min each and pins and needles in her left leg. The events were reported as serious medically significant. The outcome of events was recovered on 01Jun2021. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1411620 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-03
Onset:2021-06-01
Submitted: 0000-00-00
Entered: 2021-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW3143 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Nausea, Vaccination site pain, Vomiting
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: GLUCOPHAGE [METFORMIN HYDROCHLORIDE]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Polycystic ovary
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021657229

Write-up: Vomiting; Pain at injection site; nausea; dizziness; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202106050628393050-JHVFV, Safety Report Unique Identifier GB-MHRA-ADR 25425057. A 29-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 03Jun2021 (Lot Number: EW3143) as first dose, single for COVID-19 immunisation. Medical history included polycystic ovary. Patient has not had symptoms associated with COVID-19 and not had a COVID-19 test. Patient is not enrolled in clinical trial. Patient is not pregnant. Concomitant medication included metformin hydrochloride for polycystic ovary. The patient experienced vomiting on 05Jun2021. On unspecified date in Jun2021, the patient experienced pain at injection site, nausea and dizziness. Patient has not tested positive for COVID-19 since having the vaccine. Outcome of all the events was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1411698 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-01
Onset:2021-06-01
   Days after vaccination:31
Submitted: 0000-00-00
Entered: 2021-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Mass, Peripheral swelling, Skin burning sensation
SMQs:, Cardiac failure (broad), Angioedema (broad), Peripheral neuropathy (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GRPFIZER INC2021675370

Write-up: This is a spontaneous report from a non-contactable consumer (patient) through the medical information team. A female patient of an unspecified age received first dose of bnt162b2, via an unspecified route of administration on May2021 as, SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient reported that on Jun2021 the upper part of the hand in an area the size of a pea, if she touches something on it, it feels like it is burned since 5 days prior. On 08Jun2021 she had the same feeling under her index finger. It might be a little swollen, but she could not see. The outcome of the events was reported as unknown. Information about batch number was not available and is going to be requested upon FU


VAERS ID: 1411817 (history)  
Form: Version 2.0  
Age: 61.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-06-01
Submitted: 0000-00-00
Entered: 2021-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Medical observation, Pain in extremity, Vertigo
SMQs:, Anticholinergic syndrome (broad), Vestibular disorders (narrow), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Medical observation; Result Unstructured Data: Not reported
CDC Split Type: ITJNJFOC20210623263

Write-up: A FEW MINUTES AFTER ADMINISTRATION, FOLLOWED BY LOSS OF CONSCIOUSNESS; A FEW MINUTES AFTER ADMINISTRATION, SUBSEQUENT STUNNING SENSE AND DIZZINESS; A FEW MINUTES AFTER ADMINISTRATION, ARM PAIN; This spontaneous report received from a health care professional via a Regulatory Authority [EMEA EVHUMAN NLP, IT-MINISAL02-739266] concerned a 61 year old male. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 21C10-03 expiry: UNKNOWN) 1) 1 dosage forms, 1 total administered on 01-JUN-2021 for SARS-COV-2 vaccination. No concomitant medications were reported. On 01-JUN-2021, a few minutes after administration the patient experienced arm pain and subsequent stunning sense and dizziness, followed by loss of consciousness. Laboratory data (dates unspecified) included: Medical observation (NR: not provided) Not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from a few minutes after administration, followed by loss of consciousness, a few minutes after administration, subsequent stunning sense and dizziness, and a few minutes after administration, arm pain. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0: 20210623263-covid-19 vaccine ad26.cov2.s-a few minutes after administration followed by loss of consciousness, a few minutes after administration subsequent stunning sense and dizziness. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). 20210623263-covid-19 vaccine ad26.cov2.s- a few minutes after administration arm pain. This event(s) is labeled per RSI and is therefore considered potentially related.


VAERS ID: 1411821 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-06-01
Submitted: 0000-00-00
Entered: 2021-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Hemianaesthesia, Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Eosinophilic pneumonia (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITJNJFOC20210627854

Write-up: HYPOESTHESIA RIGHT SIDE OF THE FACE/RIGHT CRANIAL REGION; RIGHT UPPER LIMB MUSCLE PAIN; This spontaneous report received from a physician via a Regulatory Authority [EMEA EVHUMAN NLP, IT-MINISAL02-740563] concerned a 46year old female. The patient''s weight was 65 kilograms, and height was 165 centimeters. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: xd985 expiry: UNKNOWN) .5 ml,1 total administered on 01-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-JUN-2021, the patient experienced hypoesthesia right side of the face/right cranial region, edema in the right side of the face, right upper limb muscle pain and was hospitalized at facility (date unspecified). And the patient reported, he accessed to the emergency room. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the hypoesthesia right side of the face/right cranial region and right upper limb muscle pain was not reported. This report was serious (Hospitalization Caused / Prolonged).; Reporter''s Comments: facility; Sender''s Comments: V0: 20210627854-covid-19 vaccine ad26.cov2.s- hypoesthesia right side of the face/right cranial region. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). 20210627854-covid-19 vaccine ad26.cov2.s- right upper limb muscle pain. This event(s) is labeled per RSI and is therefore considered potentially related.


VAERS ID: 1411849 (history)  
Form: Version 2.0  
Age: 67.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-31
Onset:2021-06-01
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA4597 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement, Body temperature, Dizziness, Encephalopathy, Hypoaesthesia, Magnetic resonance imaging, Muscular weakness
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Hypertension (narrow), Vestibular disorders (broad), Chronic kidney disease (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dyslipidaemia; Hypertension (normally 130 systolic blood pressure)
Allergies:
Diagnostic Lab Data: Test Name: Blood pressure; Result Unstructured Data: Test Result:172/100 mmHg; Test Name: Blood pressure; Result Unstructured Data: Test Result:160/87 mmHg; Test Date: 20210531; Test Name: Body temperature; Result Unstructured Data: Test Result:35.9 Centigrade; Comments: before vaccination; Test Name: MRI; Result Unstructured Data: Test Result:abnormal; Comments: high signal interspersed in DWI
CDC Split Type: JPPFIZER INC2021651792

Write-up: The patient was a non-pregnant 67-year-old (also reported as 67-year and 3 month-old) female. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received prescription drug for dyslipidemia within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no allergies to medications, food, or other products. Body temperature before the vaccination was 35.9 degrees Centigrade. No family history. Other medical history included dyslipidaemia and hypertension. On 31May2021 at 16:15 (the day of vaccination, at the age of 67 years old), the patient received the first single dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number FA4597, Expiration date 31Aug2021) intramuscular in the left arm for COVID-19 immunisation. On 01Jun2021 at 15:30 (23 hours 15 minutes [also reported as 55 minutes] after the vaccination), the patient experienced adverse events was following: On 01Jun2021 around the 15:30, dizziness appeared before my eyes. From the evening of the same day until June 2, the patient''s memory deteriorated, and dizziness continued. On 03Jun2021, the patient''s right arm became weakness and numbness appeared. On an unspecified date, blood pressure reading high. A previous doctor''s examination showed that his blood pressure was as high as 172/100 mmHg. MRI showed abnormal results (high signal interspersed in DWI). At that time, the patient was referred to a brain surgeon at the hospital. In the hospital examination, the blood pressure was 160/87 mmHg (normally 130 systolic blood pressure). On 04Jun2021, symptoms on the upper limb tend to be relieved. Return home with follow-up plan to patient from outside. The outcome of the events was not recovered with treatment including antihypertensive. The reporter stated that the events resulted in Emergency room visit. Since the vaccination, the patient has not been tested for COVID-19. Additional information received from PMDA was as follows: The event term was reported as Encephalopathy. The onset day of the events was 01Jun2021 at 15:30. Outcome of the event was recovering on 04Jun2021. The reporter classified the event as serious (Can lead to disability). The causality between the event and the vaccine was Unassessable. Other possible cause of the event such as any other diseases included was that caused by hypertension. Reporter''s comment: May be causal.; Reporter''s Comments: May be causal; Sender''s Comments: Based on information available, a contribution role of the first single dose of bnt162b2 (COMIRNATY) to the onset of the events cannot be excluded due to the temporal relationship. The case will be reassessed should additional information become 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.


VAERS ID: 1411851 (history)  
Form: Version 2.0  
Age: 77.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA2453 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Aphasia, Body temperature, Magnetic resonance imaging head, Subdural haematoma
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Accidents and injuries (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Fall; Head injury (The patient fell from the stairs one month and a half ago); Hypertension
Allergies:
Diagnostic Lab Data: Test Date: 20210601; Test Name: Body temperature; Result Unstructured Data: Test Result:36.1 Centigrade; Comments: before the vaccination; Test Date: 20210603; Test Name: Head MRI; Result Unstructured Data: Test Result:Chronic subdural hematoma; Comments: chronic subdural haematoma in the left hemisphere
CDC Split Type: JPPFIZER INC2021651882

Write-up: Aphasia/difficult to speak; Chronic subdural haematoma in the left hemisphere; This is a spontaneous report from a contactable physician. This is a case received from the Agency Regulatory Authority. The regulatory authority report number is v21111519. A 77-year-old (also reported as 77-year and 8-month-old) male patient received BNT162B2 (COMIRNATY, Solution for injection), via an unspecified route of administration, on 01Jun2021 (Lot number: FA2453, Expiration date: 31Aug2021), as 1st single dose for COVID-19 immunisation. Medical history included head injury (the patient fell from the stairs one month and a half ago) in 2021 and the patient is also taking an antihypertensive drug (unspecified). On 01Jun2021, before the vaccination, the body temperature was 36.1 degrees Centigrade. On 01Jun2021 (the day of vaccination), the patient received the first dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number: FA2453, Expiration date: 31Aug2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On 01Jun2021 (after the vaccination), the patient experienced aphasia and chronic subdural haematoma in the left hemisphere. The course of the event was as follows: on 01Jun2021, after the patient received the first dose of COMIRNATY, the patient became difficult to speak. On 03Jun2021, the patient visited the reporting clinic and received a head MRI examination. The MRI showed chronic subdural haematoma in the left hemisphere. The patient was referred to the neurosurgery department of a hospital for the purpose of a surgery. On 03Jun2021 (2 days after the vaccination), the patient was admitted to the hospital. The outcome of the events was not reported (unknown). The reporting physician classified the event as serious (requiring hospitalization and can lead to disability) and assessed that the causality between the event and BNT162B2 as unassessable. Other possible cause of the event such as any other diseases was that the patient experienced head injury after he fell from stairs one month and a half ago. The reporting physician commented as follows: It was considered that there was no relation between the chronic subdural haematoma and the vaccine, but it was unknown whether it was related to enlargement of the haematoma. Follow-up attempts are needed. Further information is expected.


VAERS ID: 1411854 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY0779 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Blood pressure systolic increased, Body temperature, Heart rate, Oxygen saturation, Pruritus, Rash, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypertension (narrow), Cardiomyopathy (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210601; Test Name: blood pressure; Result Unstructured Data: Test Result:125/78 mmHg; Comments: at 13:40; Test Date: 20210601; Test Name: blood pressure; Result Unstructured Data: Test Result:110/69 mmHg; Comments: at 13:47; Test Date: 20210601; Test Name: body temperature; Result Unstructured Data: Test Result:36.7 Centigrade; Comments: before vaccination; Test Date: 20210601; Test Name: body temperature; Result Unstructured Data: Test Result:37 Centigrade; Comments: at 13:40; Test Date: 20210601; Test Name: body temperature; Result Unstructured Data: Test Result:36.1 Centigrade; Comments: at 14:47; Test Date: 20210601; Test Name: Pulse rate; Result Unstructured Data: Test Result:101; Comments: at 13:40; Test Date: 20210601; Test Name: Pulse rate; Result Unstructured Data: Test Result:84; Comments: at 13:47; Test Date: 20210601; Test Name: SPO2; Test Result: 99 %; Comments: at 13:40
CDC Split Type: JPPFIZER INC2021651987

Write-up: wheals; blood pressure: 125/78 mmHg; rash/skin eruption; itching on the back of her left hand; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21111470. The patient was a 37-year and 8-month-old female. Body temperature before vaccination was 36.7 degrees Centigrade. On 01Jun2021 at 13:28, (the day of vaccination), the patient received the first dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number EY0779, Expiration date 31Aug2021) via an unspecified route of administration as 1ST DOSE, SINGLE for COVID-19 immunisation. On 01Jun2021 at 13:38 (10 minutes after the vaccination), the patient felt itching on the back of her left hand, followed by a rash/skin eruption. At 13:40, the patient''s body temperature was 37 degrees Centigrade. Pulse rate was 101, blood pressure was 125/78 mmHg, SPO2 was 99 percentage. At 13:45, 500ml of normal saline was given, blood vessel was normal. At 13:47, POLARAMINE 2.5mg was injected intravenously. Blood pressure was 110/69 mmHg, Pulse rate was 84. After that, a rash occurred on the right arm. After the quiet observation, there was no difficulty in breathing. At 14:47, the right front arm had wheals. The others had not changed. Body temperature was 36.1 degrees Centigrade. The outcome of the events was recovering. The reporting physician classified the events as non-serious and assessed that the events were related to BNT162b2. There was no other possible cause of the event such as any other diseases. The reporting physician commented as follows: After vaccination with Comirnaty, there was no allergies. Antihistamines was given.


VAERS ID: 1411856 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA5765 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Headache, Nausea, Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021652125

Write-up: Feeling queasy strongly; Vomiting; headache; This is a spontaneous report from a contactable physician received via COVID-19 Adverse Event Self-Reporting Solution. The patient was a non-pregnant 49-year-old female. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no allergies to medications, food, or other products. The patient had no other medical history. On 01Jun2021 (the day of vaccination), the patient received the first single dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number FA5765, Expiration date 30Sep2021) intramuscular in the left arm for COVID-19 immunization. On 01Jun2021 after the vaccination, the patient experienced feeling queasy strongly, vomiting and headache. The reporter stated the events result in doctor or other healthcare professional office/clinic visit. The outcome of the event was recovered with treatment including intravenous drip and administration of oral medicine. Since the vaccination, the patient has not been tested for COVID-19.


VAERS ID: 1411867 (history)  
Form: Version 2.0  
Age: 79.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-24
Onset:2021-06-01
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY0779 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cerebral infarction
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021653795

Write-up: Cerebral infarction; This is a spontaneous report from a contactable physician via medical information team. The patient was a 79-year-old female. Patient''s medical history were not reported. On 24May2021 (the day of vaccination), the patient received the first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number EY0779, Expiration date 31Aug2021) via an unspecified route of administration at age of 79 years old as a single dose for COVID-19 immunization. On 01Jun2021 (8 days after the vaccination), the patient experienced cerebral infarction. On an unspecified date, the patient was admitted to the hospital and was currently hospitalized for treatment and the hospitalization would take about two weeks. The event outcome was not provided. The reporting physician didn''t provide event seriousness and the causality between the event and bnt162b2.; Sender''s Comments: Considering the temporal association, a causal association between administration of bnt162b2 and the onset of cerebral infarction cannot be 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.


VAERS ID: 1411888 (history)  
Form: Version 2.0  
Age: 96.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-03
Onset:2021-06-01
Submitted: 0000-00-00
Entered: 2021-06-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY0779 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Altered state of consciousness, Body temperature, Computerised tomogram head, Hyperpyrexia, Lumbar puncture, Pneumonia aspiration, Productive cough, Pyrexia
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Large intestine carcinoma; Meningioma; Ureteric cancer
Allergies:
Diagnostic Lab Data: Test Name: Body temperature; Result Unstructured Data: Test Result:41 Centigrade; Comments: about 12 hours after vaccination; Test Date: 20210604; Test Name: Body temperature; Result Unstructured Data: Test Result:42 Centigrade; Test Date: 20210604; Test Name: Body temperature; Result Unstructured Data: Test Result:39.8 Centigrade; Comments: 07:40; Test Date: 20210604; Test Name: Body temperature; Result Unstructured Data: Test Result:41 Centigrade; Comments: 11:00; Test Name: Head CT; Result Unstructured Data: Test Result:nothing abnormal; Test Name: lumbar puncture; Result Unstructured Data: Test Result:nothing abnormal
CDC Split Type: JPPFIZER INC2021653911

Write-up: Hyperthermia(42 centigrade degrees)/hyperthermia with 41 degree centigrade; terrible sputum; pyrexia with 39.8 degree centigrade; Consciousness disturbed; pneumonia aspiration of swallow dysfunction; This is a spontaneous report from a contactable physician and another contactable physician received from the regulatory authority. Regulatory authority report number is v21112082. The patient was a 96-year-old male. Prior to vaccination, the patient was not diagnosed with COVID-19. On 13May2021, the patient previously received the first single dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number unknown) via an unspecified route of administration in the left arm at age of 96 years for COVID-19 immunization. On 03Jun2021 (the day of vaccination), the patient received the second single dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number unknown) intramuscular in the left arm at age of 96 years for COVID-19 immunization. On 04Jun2021 (1 day after the vaccination), the patient experienced Consciousness disturbed, Hyperthermia (42 centigrade degrees). The outcome of the event was recovering with treatment. The events resulted in Hospitalized. Since the vaccination, whether the patient had been tested for COVID-19 was unknown. According to another physician from RA: The patient was 96 years and 4 months old male. Patient''s history according to the Vaccine Screening Questionnaire (including underlying diseases, allergies, vaccinations received or diseases developed within the last month, medications used, past adverse drug reaction history, and growth status) included large intestine carcinoma, ureteric cancer and meningioma. On 03Jun2021 (the day of vaccination), the patient received the second single dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number EY0779, Expiration date 31Aug2021 ) for COVID-19 immunization. On 04Jun2021 (next day of vaccination), the patient experienced the following events. Clinical course of the event was reported as follows: On 12May2021(as reported), there was not any adverse event was confirmed(first dose). On 03Jun2021(the day of the second vaccination), the second dose of vaccination was performed. On 04Jun2021 at 07:40 (next day of vaccination), there was pyrexia with 39.8 degree centigrade, consciousness disturbed was confirmed, and also terrible Sputum. The visiting nurse clapped the patient''s back. On 04Jun2021 From 11:00 (next day of vaccination), there was hyperthermia with 41 degree centigrade. On 04Jun2021 From 11:30 (next day of vaccination), consciousness disturbed appeared, Emergency aid was requested. On 04Jun2021 (next day of vaccination), the patient was admitted to the hospital. The reporting physician classified the event as serious (hospitalized from 04Jun2021) and assessed that the causality between the event and bnt162b2 as unassessable.There was no other possible cause of the event such as any other diseases. The reporting physician commented as follows: Though about 12 hours after vaccination, there was pyrexia of 41 degree centigrade and confirmed as consciousness disturbed. Since there was nothing abnormal was shown in head CT and lumbar puncture, moreover consciousness disturbed improved over time, consider the consciousness disturbed was caused by pyrexia. Also, pneumonia aspiration of swallow dysfunction (Jun2021) accompanied by consciousness disturbed was also confirmed. The outcome of the event Consciousness disturbed and was Hyperthermia (42 centigrade degrees) was recovering, other events were unknown.


VAERS ID: 1411892 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Internal haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetes mellitus; Hypercholesterolaemia
Allergies:
Diagnostic Lab Data: Test Date: 202106; Test Name: blood tests; Result Unstructured Data: Test Result:unknown results
CDC Split Type: JPPFIZER INC2021653970

Write-up: Inside of both lower limbs internal haemorrhage; This is a spontaneous report received from a contactable physician via a Pfizer sales representative.The patient was a 73-year-old male. Underlying disease included Diabetes mellitus and Hypercholesterolaemia.On 01JUN2021 (the day of vaccination), the patient received the first single dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number unknown) for COVID-19 immunisation.The patient experienced Inside of both lower limbs internal haemorrhage in Jun2021. However, because the patient was not exercising normally, internal bleeding was unlikely. Currently, blood tests were being performed just in case in Jun2021, while the results were awaited. At the same time, the patient was taking laxatives.The outcome of the event was recovering. Seriousness and the causality between the suspect drug and the event was not provided. The information on the batch number has been requested.; Sender''s Comments: Based on very limited available information and only on the temporal relationship, the reasonable possibility of an association between ''Inside of both lower limbs internal haemorrhage'' and suspect product BNT162B2 cannot be completely ruled out. Detailed information on clinical course of reported event, concomitant medications, lab results, treatment will allow a medically meaningful assessment of the case. 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.


VAERS ID: 1411953 (history)  
Form: Version 2.0  
Age: 64.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement, Hot flush, Limb discomfort, Oropharyngeal discomfort, Palpitations
SMQs:, Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hypertension (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210601; Test Name: blood pressure; Result Unstructured Data: Test Result:increased mmHg
CDC Split Type: JPPFIZER INC2021656733

Write-up: Blood pressure increased; Hot flush; Palpitations; Pharynx strange sensation; Heavy feelings in shoulders remained when the patient arrvied at the hospital; This is a spontaneous report from a contactable physician received via COVID-19 Vaccine Adverse Event Reporting System (COVAES). The patient was a non-pregnant 64-year-old female. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient''s other medical history was unknown. The patient had no allergies. On 01Jun2021 at 09:30, the patient received the first single dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number unknown because the number was not provided) at the age of 64-year-old, intramuscular in the left arm for COVID-19 immunization. On 01Jun2021 at 09:45, the patient experienced events. Clinical course was reported as follows: 5min after the injection, the patient experienced hot flush and palpitations. Blood pressure increased and pharynx strange sensation occurred, too. Heavy feelings in shoulders remained when the patient arrived at the hospital. Consciousness and vital signs were stable. The outcome of the event was unknown with treatment of analgesic antipyretic and orally taking antihistamine drugs. The reporter stated the events result in Doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient has not been tested for COVID-19. Information on the lot/batch number has been requested.; Sender''s Comments: Based on the information provided, known drug safety profile and plausible temporal association, the causality between the suspect drug and the events cannot be excluded. The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study 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.


VAERS ID: 1411968 (history)  
Form: Version 2.0  
Age: 58.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY4834 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement, Cerebral infarction, Cold sweat, Dizziness, Dyspnoea, Heart rate, Heart rate increased, Hemiplegia, Lacunar infarction, Magnetic resonance imaging, Muscular weakness, Oxygen saturation, Physical deconditioning, Vaccination site pain
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, arterial (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Hypertension (narrow), Cardiomyopathy (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), Vestibular disorders (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210604; Test Name: Blood pressure measurement; Result Unstructured Data: Test Result:190/110 mmHg; Test Date: 20210604; Test Name: Heart rate; Result Unstructured Data: Test Result:120; Test Date: 20210604; Test Name: MRI; Result Unstructured Data: Test Result:Cerebral infarction; Test Date: 20210604; Test Name: SPO2; Test Result: 98 %
CDC Split Type: JPPFIZER INC2021658191

Write-up: paralysis on the right side; Lacunar infarction; Cerebral infarction; Light-headed feeling; Cold sweat; blood pressure increased; pulse increased; Dyspnoea/Shortness of breath; weakness of right upper body; vaccination site pain; Physical deconditioning; This is a spontaneous report from a contactable pharmacist received from the regulatory authority. Regulatory authority report number is v21111863 and v21111932. The patient was a 58-year and 10-month-old male. On 01Jun2021 at 15:00 (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EY4834, Expiration date 31Aug2021) at age of 58-year and 10-month-old via an unspecified route of administration as a single dose for COVID-19 immunization. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). The patient''s concomitant medications were not reported. On 04Jun2021 (3 days after the vaccination), the patient experienced Lacunar infarction. The course of the event was as follows: On 01Jun2021, the patient received COVID-19 vaccine in reporter''s hospital. (The patient complained of pain at the site of vaccination immediately after the vaccination, which was reported to the affairs department). The patient phoned to the call center and said that he experienced physical deconditioning after the vaccination (Jun2021). The patient was told that he should be treated at the hospital where he received vaccine, then patient came to hospital on 04Jun2021. When the patient was visiting reporter''s hospital, there were Light-headed feeling and cold sweat and patient took a rest in bed/lay still in the disposal room. Blood pressure measurement was 190/110mmHg, Heart rate was 120, SPO2 was 98%. There were Dyspnoea/Shortness of breath and weakness of right upper body. MRI was performed and there were findings of cerebral infarction. Hospitalization was recommended for rehabilitation purposes and the patient discussed whether to be hospitalized. On 05Jun2021, symptoms worsened, so he came to the hospital. 3+/5 paralysis on the right side and was hospitalized on the day (05Jun2021). On 07Jun2021, the patient came back to the hospital again and decided to admit to the hospital. On 05Jun2021 (4 days after the vaccination), the outcome of the events was not recovered. The reporting pharmacist classified the event as serious(Hospitalization from 05Jun2021; Likely to be disability) and assessed that the causality between the event and BNT162B2 as unassessable. There was no other possible cause of the event such as any other diseases.


VAERS ID: 1411970 (history)  
Form: Version 2.0  
Age: 89.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-31
Onset:2021-06-01
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX3617 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Body temperature, Coma scale, Dysstasia, Magnetic resonance imaging, Somnolence
SMQs:, Anticholinergic syndrome (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: WARFARIN; E KEPPRA
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; Cardiac failure congestive; Consciousness disturbance transient; Dementia; Epilepsy (Epilepsy in the elderly); Transient loss of consciousness
Allergies:
Diagnostic Lab Data: Test Date: 20210602; Test Name: Blood sampling; Result Unstructured Data: Test Result:no significant change; Test Date: 20210531; Test Name: Body temperature; Result Unstructured Data: Test Result:35.8 Centigrade; Comments: before vaccination; Test Date: 20210602; Test Name: CS; Result Unstructured Data: Test Result:II-10; Test Date: 20210602; Test Name: MRI; Result Unstructured Data: Test Result:no lesion
CDC Split Type: JPPFIZER INC2021658209

Write-up: Somnolence; Became difficult in standing; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21111858. The patient was a 89-year and 3-month-old male. Body temperature before vaccination was 35.8 degrees Centigrade. The patient had atrial fibrillation, cardiac failure congestive, epilepsy of elderly and dementia. The patient was taking warfarin and levetiracetam (E KEPPRA) concomitantly. On 31May2021 at 15:24 (the day of vaccination), the patient received the first dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number EX3617, Expiration date 31Aug2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On 01Jun2021 at 15:30 (1 day after the vaccination), the patient experienced somnolence and became difficult in standing. The course of the event was as follows: The patient visited the hospital regularly for cardiac failure and other diseases had multiple times of visit for transient loss of consciousness/consciousness disturbance transient. The patient was also taking antiepileptic drug for epilepsy of elderly. The patient received the vaccination of BNT162B2 on 31May2021. There was no significant change in the morning on 01Jun2021, and from around 15:30, the patient experienced somnolence and became difficult in standing. Because the symptoms persisted on 02Jun2021, the patient visited the hospital by ambulance. During the visit, neither somnolence nor paralysis was observed with coma scale (CS) II-10. MRI showed no lesion and blood sampling showed no significant change. After hospitalization, somnolence improved. On 03Jun2021 (3 days after the vaccination), the patient was admitted to the hospital. The outcome of the event was not reported. The reporting physician classified the event as serious (Hospitalized) and assessed that the causality between the event and BNT162B2 as unassessable. Other possible cause of the event such as any other diseases was that the patient had medical history of consciousness disturbance transient.


VAERS ID: 1411981 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA5765 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Headache, Nausea, Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021658435

Write-up: Strong queasy; vomiting; headache; This is a spontaneous report from the contactable physician received from the Agency. Regulatory authority report number is v21111720. The patient was 49-year and 9-month-old female. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status, etc.). On 01Jun2021 at 15:30 (the day of vaccination), the patient received the first dose of bnt162b2 ( COMIRNATY Intramuscular injection, Lot number: FA5765, expiration date: 30Sep2021). Event onset date was reported on 01Jun2021 at 19:00. Clinical course of the event was reported as follows: Strong queasy, vomiting and headache was continued. Symptoms peaked around midday on 02Jun2021 (1 day after vaccination),. after intravenous injection of Primperan, orally taken LOXONIN, Nauzelin, MUCO 2A. on 03Jun2021 (2 days after vaccination), although the symptoms decreased, the patient asked to stay still for 1 day at own home on 04Jun2021 (3 days after vaccination), started with general improvement in symptoms. The reporter classified the event as non-serious and assessed the causality between the event and the vaccine as related. On 04Jun2021 (3 days after vaccination), the outcome of the events was recovering. The reporter commented as follows: The patient complained of symptoms of strong queasy and the second vaccination was discontinued.


VAERS ID: 1411992 (history)  
Form: Version 2.0  
Age: 20.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET9096 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Body temperature, Depressed level of consciousness, Feeling abnormal, Heart rate, Oxygen saturation, Pallor, Presyncope, Urinary incontinence
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Vasovagal reaction (experienced VVR when receiving dental anesthesia and intravenous blood sampling in the past)
Allergies:
Diagnostic Lab Data: Test Date: 20210601; Test Name: Blood pressure; Result Unstructured Data: Test Result:121/83; Comments: 28 minutes after the vaccination; Test Date: 20210601; Test Name: Blood pressure; Result Unstructured Data: Test Result:104/78; Comments: 15 minutes after the vaccination; Test Date: 20210601; Test Name: Body temperature; Result Unstructured Data: Test Result:36.3 Centigrade; Comments: Before vaccination; Test Date: 20210601; Test Name: Body temperature; Result Unstructured Data: Test Result:37.6 Centigrade; Comments: Pyrexia 28 minutes after the vaccination; Test Date: 20210601; Test Name: Heart rate; Result Unstructured Data: Test Result:73; Comments: 28 minutes after the vaccination; Test Date: 20210601; Test Name: Heart rate; Result Unstructured Data: Test Result:68; Comments: 15 minutes after the vaccination; Test Date: 20210601; Test Name: Oxygen saturation; Test Result: 98 %; Comments: 28 minutes after the vaccination; Test Date: 20210601; Test Name: Oxygen saturation; Test Result: 98 %; Comments: 15 minutes after the vaccination
CDC Split Type: JPPFIZER INC2021658861

Write-up: consciousness decreased; urinary incontinence; Pallor facial; feeling bad; vasovagal reflex; This is a spontaneous report from a contactable other HCP received from the regulatory authority. Regulatory authority report number is v21111849. The patient was a 20-year-old female. Body temperature before vaccination was 36.3 degrees Centigrade. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). On 01Jun2021 at 15:20 (the day of vaccination), the patient received the first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number ET9096, Expiration date 31Jul2021, dosage 0.3 ml) via intramuscular injection of administration on the left upper arm as a single dose for COVID-19 immunization. On 01Jun2021 at 15:25 (5 minutes after the vaccination), the patient experienced vasovagal reflex. On 02Jun2021 (1 day after the vaccination), the outcome of the event was recovered. The course of the event was as follows: On 01Jun2021 at 15:20 (the day of vaccination), at the group vaccination Venue, the patient received the COMIRNATY vaccine 0.3 ml on the left upper arm via intramuscular injection. The patient was observed for 15 minutes while sitting on the seat. On 01Jun2021 at 15:25 (5 minutes after the vaccination), the patient started feeling bad. On 01Jun2021 at 15:30 (10 minutes after the vaccination), the nurse on patrol asked the patient about her feeling, while she was facing the floor. The patient answered: ''not feeling well'' immediately before the patient could not keep the posture on seat and urinary incontinence was found. The patient experienced hazy consciousness. With the support of the nurse, the patient could avoid falling from the chair. Immediately, when the reporter came to check, the patient was lying on bed. The consciousness had recovered and the patient answered: ''I was alright''. The patient had Pallor facial. Vomiting was not observed. On 01Jun2021 at 15:35 (15 minutes after the vaccination), the patient was moved on stretcher. At this moment, the blood pressure was 104/78. Heart rate was 68. Oxygen saturation was 98%. On 01Jun2021 at 15:48 (28 minutes after the vaccination), the patient visited the outpatient of internal medicine. At this moment, the consciousness was clear. No such symptom as queasy or vomiting was found. No skin symptom or wheezing was found. The blood pressure was 121/83. Heart rate was 73. Oxygen saturation was 98%. Pyrexia to 37.6 centigrade was observed. It was diagnosed as VVR. The patient was observed at rest. On 01Jun2021 at 16:18 (58 minutes after the vaccination), the symptoms did not worsen. The patient was picked home by the guarantor (family). The reporting other HCP classified the event as non-serious and assessed that the event was related to bnt162b2. There was no other possible cause of the event such as any other diseases. The reporting other HCP commented as follows:a The patient had experienced VVR when receiving dental anesthesia and intravenous blood sampling, in the past, but did not notify us. This time, the episode was diagnosed as VVR. The case was reported because the patient experienced consciousness decreased and urinary incontinence. The patient decided not to receive the second dose of corona virus vaccine after talking with her guarantor.


VAERS ID: 1412104 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-06-01
Submitted: 0000-00-00
Entered: 2021-06-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Haematoma, Platelet count, Thrombocytopenia
SMQs:, Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Systemic lupus erythematosus (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Obesity (BMI 30.0)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210603; Test Name: Thrombocyte count; Result Unstructured Data: 37 nL; Comments: No more information; Test Date: 20210603; Test Name: Thrombocyte count; Result Unstructured Data: 45 nL; Comments: No more information; Test Date: 20210603; Test Name: Blood pressure; Result Unstructured Data: 156/100
CDC Split Type: NLJNJFOC20210625034

Write-up: PLATELETS FALLING; VARIOUS HEMATOMAS ON THIGHS, GROIN, ARMPIT, UPPER ARM, DECOLLETAGE, SIZE OF A 2 COIN; This spontaneous report received from a consumer via a Regulatory Authority [EMEA EVHUMAN NLP, NL-LRB-00566785] concerned a 56-year-old female. The patient''s weight was 93 kilograms, and height was 176 centimeters. The patient''s concurrent conditions included obesity, BMI (body mass index) reported as 30.0. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 21C10-02 expiry: UNKNOWN) dose was not reported, frequency 1 total, 0.5 ml, administered on 20-MAY-2021 for covid-19 immunisation. No concomitant medications were reported. On 01-JUN-2021, the patient experienced platelets falling and various hematomas on thighs, groin, armpit, upper arm, decolletage, size of a coin. On 03-JUN-2021, Laboratory data included: Blood pressure as 156/100, and Thrombocyte count as 37/nL and 45/nL. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from platelets falling, and various hematomas on thighs, groin, armpit, upper arm, decolletage, size of a coin. This report was serious (Other Medically Important Condition).; Sender''s Comments: 20210625034-covid-19 vaccine ad26.cov2.s-platelets falling. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).


VAERS ID: 1412113 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-06-01
Submitted: 0000-00-00
Entered: 2021-06-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN XD986 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Venous thrombosis
SMQs:, Embolic and thrombotic events, venous (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PLJNJFOC20210628859

Write-up: EXTENSIVE VENOUS THROMBOSIS; This spontaneous report received from a physician concerned a 25 year old male with unknown ethnicity and race. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: XD986, and expiry: UNKNOWN) dose was not reported, 1 total administered on 01-JUN-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On unspecified date of JUN-2021, the neurologist, an unregistered doctor stated that patient had an extensive venous thrombosis and was hospitalized. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of extensive venous thrombosis was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender''s Comments: V0-20210628859-covid-19 vaccine ad26.cov2.s -Extensive Venous Thrombosis-This event is considered un-assessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the events.


VAERS ID: 1414849 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-04
Onset:2021-06-01
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anxiety, Depressed mood, Facial paralysis, Feeling abnormal, Feeling cold, Pain, Road traffic accident, Vaccination site movement impairment
SMQs:, Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Depression (excl suicide and self injury) (narrow), Hearing impairment (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CAPFIZER INC2021676769

Write-up: facial paralysis/temporary paralysis left side of face and jaw; almost had three car accidents while driving on nonhighway; brain fog; feeling achy and funky; feeling achy and funky; could barely lift arm which had received the injection.; freezing sensation; felt anxious; The initial safety information received was reporting only non-serious adverse drug reactions, upon receipt of follow-up information on (09Jun2021), this case now contains serious adverse reactions. Information processed together. This is a spontaneous report from a contactable consumer (patient). A 40-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 04Jun2021 (Batch/Lot number was not reported) in the arm as UNKNOWN, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in Jun2021, the patient was feeling achy and funky, and could barely lift arm which had received the injection. He also experienced freezing sensation and felt anxious. On 09Jun2021, the patient had brain fog, almost had three car accidents while driving on nonhighway (due to not thinking clearly/brain fog), and facial paralysis/temporary paralysis left side of face and jaw. Unknown if patient receive treatment for facial paralysis, almost had three car accidents, freezing sensation, felt anxious, and brain fog. The outcome of the events feeling achy and funky, could barely lift arm which had received the injection and brain fog was recovering; outcome of felt anxious was not recovered; while the other events was recovered on an unspecified date. Information about lot/batch number has been requested.


VAERS ID: 1415558 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-25
Onset:2021-06-01
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3558 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Facial paralysis, SARS-CoV-2 test
SMQs:, Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Hearing impairment (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Gardner''s syndrome
Allergies:
Diagnostic Lab Data: Test Date: 20200910; Test Name: SARS-CoV-2 test; Test Result: Negative
CDC Split Type: FRPFIZER INC2021682033

Write-up: left facial paralysis a frigore/facial palsy; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority. A 48-year-old female patient received first dose of BNT162B2 (Comirnaty; Solution for injection; Lot number: FC3558) intramuscularly on 25May2021 as single dose for COVID-19 immunisation. Medical history of the patient included Gardner''s syndrome. Concomitant medications were not reported. Patient was tested negative for COVID-19 (SARS-CoV-2 test) on 10Sep2020. On 01Jun2021, seven days after administration of first dose of vaccination, the patient experienced left facial paralysis a frigore/facial palsy. Outcome of the event was not recovered. NB: Imputation made without prejudice to the elements of investigation which could be carried out within the framework of legal or amicable compensation procedures. No follow-up attempts are possible. No further information is expected. Information about batch number has been obtained.


VAERS ID: 1415619 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-30
Onset:2021-06-01
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH BNT162B2 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cough, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: IBUPROFEN; PARACETAMOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Ache wrists; Flu symptoms
Allergies:
Diagnostic Lab Data: Test Date: 20210603; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021657855

Write-up: persistent cough; Cough; This is a spontaneous report. A 37-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), the first dose via an unspecified route of administration on 30May2021 (Batch/Lot Number: BNT162b2) as single dose for covid-19 immunization. Medical history included ache wrists from an unknown date, flu symptoms from an unknown date. No known issues. Patient had not had symptoms associated with COVID-19. Patient was not enrolled in clinical trial. Concomitant medications included ibuprofen taken for arthralgia from 22May2021 to 02Jun2021; paracetamol taken for flu symptoms from 01Jun2021 to an unspecified stop date. The patient experienced persistent cough on an unspecified date with outcome of recovering, cough on 01Jun2021 with outcome of not recovered. Occasional but persistent cough, still occurring 3 days after vaccination. Patient had not tested positive for COVID-19 since having the vaccine. The events were reported as serious due to medically significant. The patient underwent lab tests and procedures which included COVID-19 virus test: no - negative covid-19 test on 03Jun2021. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1415632 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-31
Onset:2021-06-01
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW3143 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Disturbance in attention, Fatigue, Hypersomnia, Hypoaesthesia oral, Lip swelling, Palpitations, Pyrexia, Rhinorrhoea, SARS-CoV-2 test, Sneezing, Swelling face
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Depression (excl suicide and self injury) (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Bee sting hypersensitivity; Penicillin allergy; Sulfonamide allergy; Tingling of extremity; Comments: I am allergic to penicillin, sulphas, & bee stings, so I assume there may be another allergy I am susceptible to that has not been discovered. Patient has not had symptoms associated with COVID-19 Patient is not enrolled in clinical trial
Allergies:
Diagnostic Lab Data: Test Date: 20210603; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021657341

Write-up: Swelling face; lip felt a bit numb; Lip swelling; Heart pounding; fever; Runny nose; sneezing; Fatigue; slept for most of the day; not focus or concentrate on his work; This is a spontaneous report from a contactable consumer. This is a report received from a regulatory authority. A 34-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 31May2021 (lot number EW3143), as a 1st dose, single dose for COVID-19 immunization. Medical history included tingling of extremity and allergic to penicillin, sulphas, & bee stings. Patient assumed there may be another allergy as he is susceptible to that has not been discovered. Patient has not had symptoms associated with COVID-19. Patient is not enrolled in clinical trial.The patient''s concomitant medications were not reported. The patient experienced fatigue, sneezing, slept for most of the day, and runny nose, not focus or concentrate on his work, and fever on 01Jun2021; lip swelling, lip felt a bit numb, and heart pounding on 02Jun2021; and swelling face on 03Jun2021. Clinical course was reported as follows: the day after the vaccination, patient had a runny nose and it post-nasal drip like symptoms with the odd sneezing here and there. His body felt very fatigued and slept for most of the day as he could not focus or concentrate on his work (working on computer at home). During the night, he struggled with an intense fever, and woke up at 3 am with his heart pounding very hard in his chest (at around 73 bpm, recorded with his phone). His top lip was extremely swollen and felt a bit numb, drinking water could not feel the water hitting his lips. He went back to sleep and woke up at 7am with his entire face swollen (including his lips), which disappeared about 30 minutes later. Since then, patient had a constant runny nose with more sneezing, fearing he had contracted COVID, he took 2 at home tests on the 03Jun2021 and both returned negative. As of 04Jun2021, he still have some uncomfortable feeling in my nose but the sneezing has stopped. The events were considered medically significant. The patient had negative COVID-19 test on 03Jun2021. Based off the documentation for the vaccine, patient has not taken any medication to combat the symptoms. The patient has recovered from the events, fatigue, lip swelling, swelling face, and heart pounding on 03Jun2021 and sneezing on 04Jun2021; recovering from runny nose; not recovered from fever; and outcome of the remaining events was unknown. No follow-up attempts are possible. No further information is expected. 1


VAERS ID: 1415647 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-31
Onset:2021-06-01
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Lymphadenopathy, Oropharyngeal pain, SARS-CoV-2 test, Throat irritation, Tonsillitis
SMQs:, Agranulocytosis (broad), Oropharyngeal infections (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased; Comments: Patient has not had symptoms associated with COVID-19 Patient is not enrolled in clinical trial Patient is not pregnant,Patient is not currently breastfeeding
Allergies:
Diagnostic Lab Data: Test Date: 20210604; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021657503

Write-up: Sore throat; feels like tonsillitis - very scratchy throat; feels like tonsillitis - very scratchy throat / swollen tonsils; lymph nodes at side of neck were sensitive and tender to touch; This is a spontaneous report from a contactable consumer received from the Regulatory Authority Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202106041144048530-GFIQT. Safety Report Unique Identifier (GB-MHRA-ADR 25419664). A 34-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 31May2021 (Batch/Lot number was not reported) as single dose for Covid-19 immunisation. Medical history included suppressed lactation. Patient has not had symptoms associated with COVID-19. Patient was not enrolled in clinical trial. Patient was not pregnant at the time of vaccination. Patient was not currently breastfeeding. The patient''s concomitant medications were not reported. The patient reported it felt like tonsillitis - very scratchy throat, painful to swallow with swollen tonsils, lymph nodes at side of neck were sensitive and tender to touch, they started 24 hours after the vaccine (01Jun2021) and still here 4 days after vaccine. The patient experienced sore throat on 02Jun2021. Patient has not tested positive for COVID-19 since having the vaccine. The patient underwent lab tests which included COVID-19 virus test: no - negative covid-19 test on 04Jun2021. At the time of reporting, the patient was recovering from the events. The regulatory authority assessed the events as medically significant. No follow-up attempts are possible; information about Batch/Lot Number cannot be obtained. No further information is expected.


VAERS ID: 1415653 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-21
Onset:2021-06-01
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW4109 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Dyspnoea, Ear pain, Lymph node pain, Lymphadenopathy, Muscular weakness, Pain in extremity, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Peripheral neuropathy (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Cardiomyopathy (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CITALOPRAM; SALBUTAMOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma; Depression; Lactation decreased
Allergies:
Diagnostic Lab Data: Test Name: PCR test; Test Result: Negative
CDC Split Type: GBPFIZER INC2021657582

Write-up: Breathlessness; Painful arm; Lymph node pain; weakness in arm; pain shoots up to ear; Swollen lymph nodes in neck and at collar bone; weak; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202106041212580380-KIQEP. Safety Report Unique Identifier GB-MHRA-ADR 25420004. A 31-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 21May2021 (Lot Number: Ew4109) as SINGLE DOSE for COVID-19 vaccination. Medical history included suppressed lactation, depression, asthma. Patient had not had symptoms associated with COVID-19 Not had a COVID-19 test Patient was not enrolled in clinical trial. Patient was not pregnant, Patient was not currently breastfeeding.Concomitant medications included citalopram taken for depression from 20May2016; salbutamol taken for asthma from 01Sep2000. The patient experienced painful arm on 03Jun2021, lymph node pain on 03Jun2021, breathlessness on 04Jun2021. 10 days post vaccine pain in arm began, came and went until built to constant pain and weakness in arm in Jun2021, pain shoots up to ear in Jun2021. In Jun2021 the patient experienced Swollen lymph nodes in neck and at collar bone and weak. All of the events were assessed as medically significant. The patient underwent lab tests and procedures which included PCR test: negative on an unspecified date. Patient has not tested positive for COVID-19 since having the vaccine. The outcome of events was not recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1415661 (history)  
Form: Version 2.0  
Age: 20.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Chills, Dizziness, Headache, Pain in extremity, SARS-CoV-2 test, Somnolence
SMQs:, Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Vestibular disorders (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PARACETAMOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Headache; Suspected COVID-19 (Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Date: 20201007; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result: Positive.
CDC Split Type: GBPFIZER INC2021657789

Write-up: Headache; Sleepiness; Chills; Joint pain; Dizziness; Painful arm; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202106041321301750-LA2LF, Safety Report Unique Identifier GB-MHRA-ADR 25420560. A 20-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at the age of 20-year-old on 01Jun2021 (Lot number was not reported) as 1ST DOSE, SINGLE for COVID-19 immunisation. Medical history included suspected covid-19 from 07Oct2020 to an unknown date (unsure when symptoms stopped), headache. Concomitant medication included PARACETAMOL taken for headache, start and stop date were not reported. The patient experienced painful arm on 01Jun2021 with outcome of recovering, headache on 02Jun2021 with outcome of not recovered, sleepiness and dizziness both on 02Jun2021 with outcome of recovering, chills on 02Jun2021 with outcome of recovered on 03Jun2021, joint pain on 02Jun2021 with outcome of recovered on 04Jun2021. Events were reported as serious with medically significant. The patient underwent lab tests and procedures which included COVID-19 virus test: Positive on 07Oct2020. Patient is not enrolled in clinical trial. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1415666 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-27
Onset:2021-06-01
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET8885 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Headache, Maternal exposure during breast feeding, Melanoderma, Migraine, Migraine with aura, Off label use, Product use issue, SARS-CoV-2 test, Visual impairment
SMQs:, Anticholinergic syndrome (broad), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Retinal disorders (broad), Neonatal exposures via breast milk (narrow), Medication errors (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Breast feeding
Preexisting Conditions: Medical History/Concurrent Conditions: Headache; Migraine; Comments: Patient has not had symptoms associated with COVID-19 Patient is not enrolled in clinical trial Patient is not pregnant
Allergies:
Diagnostic Lab Data: Test Date: 20210604; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021657757

Write-up: Maternal exposure during breast feeding; Maternal exposure during breast feeding; Maternal exposure during breast feeding; pixelated vision; black spots; Migraine aura; migraine; headache; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202106041333334480-IZNLW. Safety Report Unique Identifier: GB-MHRA-ADR 25420570. A 37-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 27May2021 (Batch/Lot Number: Et8885) as single dose for covid-19 immunisation. Medical history included migraine, headache, ongoing breast feeding. Patient has not had symptoms associated with COVID-19 Patient is not enrolled in clinical trial Patient is not pregnant. The patient''s concomitant medications were not reported. The patient experienced headache on 01Jun2021 with outcome of recovering, migraine on 03Jun2021 with outcome of recovering, migraine aura on 04Jun2021 with outcome of recovering, maternal exposure during breast feeding, black spots and pixelated vision on an unspecified date with outcome of unknown. The patient underwent lab tests and procedures which included COVID-19 virus test: negative covid-19 test on 04Jun2021. Headaches started 01Jun in the evening then had daily. With first migraine 03Jun2021 aura lasting 20 mins. Subsequent aura 04Jun2021 lasting 1 hour followed by painful headache. Aura causing black spots and pixelated vision. Patient has not tested positive for COVID-19 since having the vaccine. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1415741 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-03
Onset:2021-06-01
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Cardiac arrest, Muscle spasms, Pain, SARS-CoV-2 test, Vaccination site pain
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Dystonia (broad), Acute central respiratory depression (broad), Cardiomyopathy (broad), Arthritis (broad), Respiratory failure (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19 (COVID-19 virus test on 27Jan2021 which resulted "Yes - Positive COVID-19 test")
Allergies:
Diagnostic Lab Data: Test Date: 20210127; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC2021657315

Write-up: Joint ache/Localised to hips and knees; Injection site pain/very painful sensation in the arm/lifting above shoulder height was very painful; Cardiac arrest; ache; Cramps in the calves; This is a spontaneous report from a contactable consumer received from the regulatory authority report number is GB-MHRA-WEBCOVID-202106041542170160-ECAKN, Safety Report Unique Identifier is GB-MHRA-ADR 25421530. A 30-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiration date unknown), via an unspecified route of administration, administered in the arm, on 03Jun2021 at 14:00, as first dose, single for COVID-19 immunization. Medical history included suspected COVID-19 from 25Jan2021 to 05Mar2021. Patient was not enrolled in clinical trial. The patient underwent a COVID-19 virus test on 27Jan2021 which resulted "Yes - Positive COVID-19 test". The patient''s concomitant medications were not reported. The patient experienced cardiac arrest, ache, and cramps in the calves, all on Jun2021; joint ache on 04Jun2021 at 14:00, and injection site pain on 04Jun2021 at 03:00. The events were reported as serious, with seriousness criteria of other medically important condition. The clinical course was reported as follows: Injection was at 2:00 pm, it was fine, no arm pain until fell asleep. Woke up at approximately 3 am, with a very painful sensation in the arm. Continued pain throughout the day, lifting above shoulder height was very painful. Joint ache started approximately 24h after injection, localised to hips and knees. Patient has not tested positive for COVID-19 since having the vaccine. The outcome of cardiac arrest, ache, cramps in the calves was recovering. The outcome of injection site pain and joint ache was not recovered. No follow-up attempts are possible, information about Batch/Lot Number cannot be obtained. No further information is expected.


VAERS ID: 1415759 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA5843 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Headache, Nausea, Pyrexia, Rash
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CITALOPRAM
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anxiety; Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021657665

Write-up: nauseous; Nausea; 2-3 hours after the vaccine i had a rash come up along my vaccine arm; Headache; Joint pain; Rash; Feverish; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202106041655374400-EME5F, Safety Report Unique Identifier GB-MHRA-ADR 25422289. A 30-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 01Jun2021 (Lot Number: FA5843) as single dose for COVID-19 immunisation at the age of 30 years old. Medical history included lactation decreased, anxiety. Unsure if patient has had symptoms associated with COVID-19, Not had a COVID-19 test, Patient is not enrolled in clinical trial, Patient is not pregnant, and Patient is not currently breastfeeding. Concomitant medication(s) included citalopram taken for anxiety from 12Nov2019. The patient experienced nauseous on an unknown date, 2-3 hours after the vaccine I had a rash come up along my vaccine arm, headache, joint pain, rash, feverish on 01Jun2021, nausea on 04Jun2021. Reported as: 2-3 hours after the vaccine I had a rash come up along my vaccine arm, chest, and other arm. It looked like small raises bumps on my skin that were not itchy or painful. At the same time my joints become sore this progressed over the next 24 hours to a point where it was painful to move. I have been feverish with a headache which has not yet resolved. After the initial signs resolved I became nauseous which also has not resolved. Patient has not tested positive for COVID-19 since having the vaccine. The outcome of nauseous on an unknown date, rash all over was recovered, headache was not recovered, joint pain recovered on 03Jun2021, rash on 01Jun2021, Feverish, nausea on 04Jun2021 was not recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1415770 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Fatigue, Haemorrhage, Muscle spasms, Neonatal disorder, Off label use, Product use issue
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Dystonia (broad), Neonatal disorders (narrow), Medication errors (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Breast feeding
Preexisting Conditions: Comments: Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test Patient is not enrolled in clinical trial Patient is not pregnant
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021657588

Write-up: fatigue; significantly heavy bleeding and cramps; cramps; Unspecified condition originating in the perinatal period; Maternal exposure during breast feeding/gave birth two months ago and am exclusively breastfeeding; Maternal exposure during breast feeding/gave birth two months ago and am exclusively breastfeeding; This is a spontaneous report from a contactable consumer (patient) received from the regulatory authority report number is GB-MHRA-WEBCOVID-202106041756201420-28TGD. A 34-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 01Jun2021 (Batch/Lot number was not reported) as 1st single dose for Covid-19 immunisation. Medical history included ongoing breast feeding. The patient''s concomitant medications were not reported. Patient had not had symptoms associated with COVID-19. Patient did not have a COVID-19 test. Patient was not enrolled in clinical trial. Patient was not pregnant. The patient experienced unspecified condition originating in the perinatal period on 02Jun2021, the patient experienced maternal exposure during breast feeding. The patient gave birth two months ago and was exclusively breastfeeding. The day after her vaccine, not long after her very light postpartum bleeding finally seemed to be completely finished, patient started what seems to be a period (AS REPORTED). Significantly heavy bleeding and cramps, accompanied by fatigue. Still going on 3 days later. Only thought to link it with vaccine after reading similar reports by other women. Patient had not tested positive for COVID-19 since having the vaccine. The outcome of fatigue, significantly heavy bleeding and cramps, unspecified condition originating in the perinatal period was not recovered, of other events was unknown. This is a serious report received with serious criteria medically significant from MHRA. No follow-up attempts are possible, Information about Batch/Lot Number cannot be obtained. No further information is expected.


VAERS ID: 1415787 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-27
Onset:2021-06-01
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET8885 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Ageusia, Fatigue, Herpes zoster, Lymphadenopathy, Pruritus, Rash, SARS-CoV-2 test, Sensitive skin, Vaccination site pain
SMQs:, Anaphylactic reaction (broad), Taste and smell disorders (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Opportunistic infections (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: EVACAL D3; FULTIUM D3; LANSOPRAZOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Shingles
Allergies:
Diagnostic Lab Data: Test Date: 20210603; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021657629

Write-up: Shingles; sensitive skin on neck and upper right arm; a heat like rash appears top of right ear and behind ear; Ageusia; can feel lymph node near base of neck, right side only day; itchy; sore arm where injection was admitted; constant tiredness; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202106041924233290-N8OG3, Safety Report Unique Identifier GB-MHRA-ADR 25423447. A 33-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE)), via an unspecified route of administration at arm on 27May2021 (Lot Number: Et8885) as single dose for COVID-19 immunisation. Medical history included herpes zoster. Patient had not had symptoms associated with COVID-19. Patient was not enrolled in clinical trial. Concomitant medications included calcium carbonate, colecalciferol (EVACAL D3) taken for osteoporosis, start and stop date were not reported; colecalciferol (FULTIUM D3) taken for osteoporosis, start and stop date were not reported; lansoprazol taken for Esophageal acid reflux, start and stop date were not reported. In 2021 the patient experienced sore arm where injection was admitted, day 2/3, small bumps starting on head and back of head, can feel lymph node near base of neck, right side only day, with sensitive skin on neck and upper right arm day 4/5, bumps on scalp because sore to touch and itchy, a heat like rash appears top of right ear and behind ear, ageusia, constant tiredness, report to Drs, appointment booked for day 8 after vaccine, day 6-7. The doctor diagnosed shingles on 01-JUN-2021 and start treatment of skin. All of the events were assessed as medically significant. The patient underwent lab tests and procedures which included COVID-19 virus test: No - Negative COVID-19 test on 03Jun2021. No test, seen by 2 Drs at the doctors surgery. Patient has not tested positive for COVID-19 since having the vaccine. The outcome of the event sensitive skin was unknown, the others was recovering. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1415803 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-25
Onset:2021-06-01
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET8885 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Menstruation delayed, SARS-CoV-2 test
SMQs:, Fertility disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021657867

Write-up: Late period; This is a spontaneous report from a contactable consumer received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202106042052405160-FQKSW, Safety Report Unique Identifier is GB-MHRA-ADR 25423968. A 32-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 25May2021 (lot number: ET8885) at single dose for COVID-19 immunization. Medical history included suppressed lactation. Patient had not had symptoms associated with COVID-19. Patient was not enrolled in clinical trial. Patient was not pregnant. Patient was not currently breastfeeding. The patient''s concomitant medications were not reported. The patient experienced late period on 01Jun2021. Patient had her vaccination 10 days before and was 6 days late for her period. She was usually very regular and had never experienced a cycle like this. This case was reported as medically significant. Patient had not tested positive for COVID-19 since having the vaccine. The patient underwent lab tests and procedures which included COVID-19 virus test: No - negative COVID-19 test. Outcome of the event was not resolved. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1415818 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-06-03
Onset:2021-06-01
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Gastrointestinal sounds abnormal, Malaise, SARS-CoV-2 test, Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210603; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative
CDC Split Type: GBPFIZER INC2021657496

Write-up: feel sick; Vomiting/Can''t keep anything down; tummy is gurgling; This is a spontaneous report from a contactable consumer, received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202106042235201560-1NZOR, Safety Report Unique Identifier is GB-MHRA-ADR 25424717. A 33-year-old patient of an unspecified gender received the first dose of BNT162B2 (Pfizer-BIONTECH COVID-19 Vaccine), via an unspecified route of administration on 03Jun2021 (Batch/Lot number was not reported) as a single dose for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient has not had symptoms associated with COVID-19 and was not enrolled in a clinical trial. The patient previously took Yasmin as a contraceptive pill. The patient started to feel sick around 6PM the day after the vaccination, 04Jun2021. The patient then started being sick about one hour later and could not keep anything down. The patient''s tummy was gurgling too on an unspecified day in Jun2021. The patient underwent lab tests and procedures which included SARS-CoV-2 test: negative on 03Jun2021 (No - Negative). The patient has not tested positive for COVID-19 since having the vaccine. Outcome of the event vomiting was not recovered, for feel sick was recovering, while for "tummy is gurgling" was unknown. The case was reported as serious (medically significant). No follow-up attempts are possible; information about the lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1415819 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-24
Onset:2021-06-01
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Haemorrhage, Menstrual disorder, Menstruation delayed, SARS-CoV-2 test
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Fertility disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Fibroids; Hemoglobin low
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021657551

Write-up: bleeding; Menstrual cycle abnormal; period didn''t come when expected and it''s never late; This is a spontaneous report from a contactable consumer, received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202106042235583320-AZBYY, Safety Report Unique Identifier GB-MHRA-ADR 25424750. A 45-year-old female patient received the first dose of BNT162B2 (Pfizer-BIONTECH COVID-19 Vaccine), via an unspecified route of administration on 24May2021 (Batch/Lot number was not reported) as a single dose for COVID-19 immunization. Medical history included uterine leiomyoma. The patient has not had symptoms associated with COVID-19 and was not enrolled in a clinical trial. The patient''s concomitant medications were not reported. The patient previously took iron. The patient experienced bleeding on an unspecified date and menstrual cycle abnormal on 01Jun2021. It was reported that her menstrual cycle had been affected. Her period didn''t come when expected and it''s never late. She''d since started bleeding out of pattern than what was normal; light bleeding. The patient has a history of fibroids and last year was on iron supplements for a year as she was near anaemia. The patient underwent lab tests and procedures which included SARSA-CoV-2 test: no - negative COVID-19 test on an unspecified date. The patient has not tested positive for COVID-19 since having the vaccine. Outcome of the event bleeding was recovered on an unspecified date, while for the other events was not recovered. The case was reported as serious (medically significant). No follow-up attempts are possible. Information about the lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1415827 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-03
Onset:2021-06-01
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH NOT KNOWN / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Dizziness, Headache, Lethargy, Myalgia, Pyrexia, SARS-CoV-2 test, Swelling face
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased; Comments: Patient has not had symptoms associated with COVID-19 Patient is not enrolled in clinical trial Patient is not pregnant,Patient is not currently breastfeeding
Allergies:
Diagnostic Lab Data: Test Date: 202106; Test Name: Temperature; Result Unstructured Data: Test Result:High; Test Date: 20210602; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021657754

Write-up: Dizziness; Lethargy; Swollen of face feeling; Headache; High temperature; Muscle pain; This is a spontaneous report from a contactable consumer or other non hcp received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202106050032518350-2SUUZ. Sender''s (Case) Safety Report Unique Identifier: GB-MHRA-ADR 25424821. A 17-years-old female patient received bnt162b2 (BNT162B2, COVID-19 MRNA VACCINE BIONTECH), dose 2 via an unspecified route of administration on 03Jun2021 (Batch/Lot Number: Not known) as 2ND DOSE, SINGLE dose for covid-19 immunization, at the age at vaccination of 17 years old. Medical history included suppressed lactation from an unknown date and unknown if ongoing. Patient has not had symptoms associated with COVID-19. Patient was not enrolled in clinical trial. Patient was not pregnant. Patient was not currently breastfeeding. Historical vaccine included first dose of COVID-19 MRNA VACCINE BIONTECH on 05Mar2021 for covid-19 immunization. The patient''s concomitant medications were not reported. The patient experienced high temperature on Jun2021 with outcome of not recovered, dizziness on 03Jun2021 with outcome of not recovered, lethargy on 03Jun2021 with outcome of not recovered, swollen of face feeling on 03Jun2021 with outcome of recovering (also reported end of event date as 04Jun2021), muscle pain on Jun2021 with outcome of not recovered, headache on 03Jun2021 with outcome of not recovered. The patient underwent lab tests which included body temperature: high on Jun2021, sars-cov-2 test: no - negative covid-19 test on 02Jun2021. Events reported as serious as medically significant. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1415838 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-06-01
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Feeling cold, Mastitis, Pain in extremity
SMQs:, Functional lactation disorders (narrow), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LEVOTHYROXINE
Current Illness: Suspected COVID-19
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021657371

Write-up: Mastitis; Shivers; Painful arm; Feeling cold; This is a spontaneous report from a contactable consumer received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202106050725336480-EAYXB. Safety Report Unique Identifier: GB-MHRA-ADR 25425115. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date (Lot Number: Not known) as 1st dose, single for Covid-19 immunisation. Medical history included suspected covid-19 from 15Mar2020 to 20Mar2020. Patient has not had a COVID-19 test. Patient was not enrolled in clinical trial. Concomitant medication included levothyroxine taken for an unspecified indication, start and stop date were not reported. The patient experienced mastitis, shivers, painful arm and feeling cold on 01Jun2021. The events were reported as non-serious. The clinical course was reported as follows: lasted for one night and one day, but was feeling much better/almost normal at the end of the day. Patient has not tested positive for COVID-19 since having the vaccine. The outcome of all events was recovered on 02Jun2021. No follow-up attempts are possible, information about batch number cannot be obtained.


VAERS ID: 1415866 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-01
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW3143 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Lymph node pain, Lymphadenopathy, Pain, SARS-CoV-2 test
SMQs:, Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210604; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021657257

Write-up: Lymph node pain; Swollen lymph nodes; pain; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202106051036504730-MO22L, Safety Report Unique Identifier is GB-MHRA-ADR 25425471. A 26-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW3143), via an unspecified route of administration on 02Jun2021 as first dose, single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19 and he was not enrolled in clinical trial. On Jun2021, the patient experienced pain; and on 04Jun2021, the patient experienced lymph node pain and swollen lymph nodes. The events were reported as serious with seriousness criteria of other medically important condition. The patient had taken paracetamol for the pains. Patient has not tested positive for COVID-19 since having the vaccine. The patient underwent COVID-19 virus test on 04Jun2021 with the following result: No - Negative COVID-19 test. The outcome of pain was unknown, while the outcome of the remaining events was not recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1415877 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-27
Onset:2021-06-01
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anger, Asthenopia, Fatigue, Headache, SARS-CoV-2 test
SMQs:, Hostility/aggression (narrow), Corneal disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Patient has not had symptoms associated with COVID-19 Patient is not enrolled in clinical trial
Allergies:
Diagnostic Lab Data: Test Date: 20201010; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021657187

Write-up: short temper; fatigue; Heavy eyes; Headache; This is a spontaneous report from a contactable consumer. This is a report received from ta regulatory authority. A 38-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number: Unknown), via an unspecified route of administration as a 1st dose, single on 27May2021 for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Patient is not enrolled in clinical trial. On an unspecified date the patient experienced short temper, fatigue and heavy eyes. On 01Jun2021, he experienced headache. Therapeutic measure taken in response of headache (pain killers). The clinical course was reported as: Headaches every day. Heavy eyes fatigue. Short temper. Pain killers not working. Patient has not tested positive for COVID-19 since having the vaccine. The case is serious (medically significant). The patient had COVID-19 Virus test (10Oct2020): no-negative covid-19 test. The outcome for short temper, fatigue and heavy eyes was unknown. The outcome for headache was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1415901 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-06-05
Onset:2021-06-01
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW3143 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Hypoaesthesia, SARS-CoV-2 test
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021657473

Write-up: Body numbness; Numbness all over; This is a spontaneous report from a contactable consumer received from the regulatory authority report number is GB-MHRA-WEBCOVID-202106051429187480-6DVMK, Safety Report Unique Identifier GB-MHRA-ADR 25425929. A 33-year-old patient of an unspecified gender received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 VACCINE), via an unspecified route of administration on 05Jun2021 (Batch/Lot Number: Ew3143) as 1st dose, single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Patient is not enrolled in clinical trial. The patient experienced numbness all over within 3 hrs of vaccine on Jun2021 and body numbness on an unspecified date. The case is serious (medically significant). The patient had COVID-19 Virus test (Unknown date): No - Negative COVID-19 test. The outcome for numbness all over and body numbness was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1415910 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Fatigue, Feeling abnormal, Insomnia, SARS-CoV-2 test, Vaccination site pain
SMQs:, Anticholinergic syndrome (broad), Dementia (broad), Vestibular disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Date: 20210605; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021657882

Write-up: Fatigue; dizziness; Spaced out; brain fog; Pain injection site; Sleeplessness; This is a spontaneous report from a contactable consumer received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202106051614477750-DUK3Z, Safety Report Unique Identifier GB-MHRA-ADR 25426109. A 31-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 01Jun2021 at 16:50 (Lot number was not reported) as single dose for covid-19 immunisation. Patient age at vaccination was 31 years old. Medical history included suppressed lactation. Patient had not had symptoms associated with COVID-19. Patient was not enrolled in clinical trial. Patient was not pregnant. Patient was not currently breastfeeding. The patient''s concomitant medications were not reported. The patient experienced dizziness on 02Jun2021 with outcome of recovering, pain injection site on 01Jun2021 with outcome of recovered on 03Jun2021, sleeplessness on 01Jun2021 with outcome of recovered on 03Jun2021, fatigue on 02Jun2021 with outcome of recovering, spaced out on 02Jun2021 with outcome of recovered on 04Jun2021, brain fog on 02Jun2021 with outcome of unknown. The patient underwent lab test which included COVID-19 virus test: negative on 05Jun2021 (No -Negative COVID-19 test). Clinical course was reported as patient had vaccine in evening approx 4.50 pm. Pain at injection site started around 5-6 hours later. That night could not sleep - extremely wakeful despite being tired. Next day (02Jun2021) felt spaced out, dizziness, brain fog and by evening significant fatigue. Similar following day but slightly less fatigued. Patient had not tested positive for COVID-19 since having the vaccine. This case was reported as serious with seriousness criteria: medically significant. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1415911 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Fatigue, Headache, Nausea, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021657864

Write-up: Headache; Fatigue; Nausea; Dizziness; This is a spontaneous report from a contactable consumer received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202106051617358470-O2URM. Safety Report Unique Identifier GB-MHRA-ADR 25426103. A 60-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 01Jun2021 (Lot number was not reported) as single dose at the age of 60-year-old for COVID-19 immunisation. The patient medical history was not reported. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number was not reported) single dose for COVID-19 immunisation. Patient has not had symptoms associated with COVID-19. Patient is not enrolled in clinical trial. The patient''s concomitant medications were not reported. The patient experienced headache, fatigue, nausea, dizziness on 01Jun2021. The patient underwent lab tests and procedures which included COVID-19 virus test: negative on an unknown date. Patient has not tested positive for COVID-19 since having the vaccine. The seriousness was reported as medically significant. The event outcome was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1416018 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-04
Onset:2021-06-01
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH NOT KNOWN / 1 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Decreased appetite, Diarrhoea, Headache, Hypoaesthesia, Lethargy, Nausea, Pyrexia, Vaccination site pain
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Date: 202106; Test Name: body temperature; Result Unstructured Data: Test Result:Fever
CDC Split Type: GBPFIZER INC2021657733

Write-up: Severe headache; Lethargic; Severe diarrhoea; Nausea; Severe pain in arm where injection was administered ( left); Occasional numbness in my cheek ( left); Fever; Loss of appetite; This is a spontaneous report from a contactable consumer (patient) received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202106052005017050-AGCHE. Safety Report Unique Identifier GB-MHRA-ADR 25426412. A 32-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 04Jun2021 (Batch/Lot Number: Not known) as 1ST DOSE, SINGLE for covid-19 immunisation. Patient in good health. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient is not enrolled in clinical trial. Patient is not pregnant. Patient is not currently breastfeeding. Medical history included lactation decreased. The patient''s concomitant medications were not reported. The patient experienced severe headache (medically significant) on Jun2021 with outcome of unknown, lethargic (medically significant) on Jun2021 with outcome of unknown, severe diarrhoea (medically significant) on Jun2021 with outcome of unknown, nausea (medically significant) on Jun2021 with outcome of unknown, severe pain in arm where injection was administered (left) (medically significant) on Jun2021 with outcome of unknown, occasional numbness in my cheek (left) (medically significant) on Jun2021 with outcome of unknown, fever (medically significant) on Jun2021 with outcome of unknown, loss of appetite (medically significant) on Jun2021 with outcome of unknown. Patient has not tested positive for COVID-19 since having the vaccine. No follow-up attempts are possible; information about lot/batch number cannot be requested.


VAERS ID: 1416043 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-04
Onset:2021-06-01
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Back pain, Musculoskeletal pain, Pain in extremity, SARS-CoV-2 test, Vaccination site pain
SMQs:, Rhabdomyolysis/myopathy (broad), Retroperitoneal fibrosis (broad), Tendinopathies and ligament disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Immunodeficiency; Lactation decreased
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021657320

Write-up: Back pain; pain in arm; dull ache at site of vaccination; pain to buttock, thigh and calf; pain to buttock, thigh and calf; This is a spontaneous report from a contactable consumer received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202106052331312410-4D2J3, Safety Report Unique Identifier GB-MHRA-ADR 25426605. A 38-year-old female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 VACCINE, Batch/Lot number: Unknown), via an unspecified route of administration on 04Jun2021 (Lot number was not reported) as 1st dose, single for COVID-19 immunization. Medical history included lactation decreased and immunodeficiency. Patient has not had symptoms associated with COVID-19. Patient is not enrolled in clinical trial. Patient is not pregnant and is not currently breastfeeding. The patient''s concomitant medications were not reported. The patient previously took sertraline. On 05Jun2021, the patient experienced back pain. On an unspecified date in Jun2021, the patient experienced pain in arm, dull ache at site of vaccination, pain to buttock, thigh and calf. The clinical course was reported as follows: Pain in arm - dull ache at site of vaccination. Began 8/9 hours following dose. Pain travelled in to back on same side as vaccination, then down into buttock, thigh and calf as day progressed. Pain stayed on same side as vaccination - no pain on right. Patient has not tested positive for COVID-19 since having the vaccine. The case is serious (medically significant). The patient had COVID-19 Virus test (Unknown date): No - Negative COVID-19 test. The outcome of the event back pain is not recovered; outcome for pain in arm, dull ache at site of vaccination, pain to buttock, thigh and calf was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1416046 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-03
Onset:2021-06-01
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA1027NPT / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Asthenia, Fatigue, Headache, Myalgia, Pain in extremity, Pyrexia, Somnolence
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test Patient is not enrolled in clinical trial
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021657240

Write-up: Headache; Fever; Joint pain; Muscle pain/Muscle soreness; sore arm; Fatigue; Drowsiness; lacked energy; This is a spontaneous report from a contactable consumer (patient) received from the Regulatory Authority (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202106060028518790-JF0HS. Safety Report Unique Identifier: GB-MHRA-ADR 25426638. A 23-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 03Jun2021 (Lot Number: FA1027NPT) as first dose, single for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19 and not had a COVID-19 test. Patient is not enrolled in clinical trial. On 04Jun2021, the patient experienced muscle pain/muscle soreness fatigue, drowsiness, fever and joint pain. On 05Jun2021, the patient experienced headache. "Since the day after my vaccine (04Jun2021), I have felt muscle pain, sore arm, fatigue, drowsiness and fever. I was unable to carry out daily tasks as I lacked energy (on unspecified date in Jun2021). I had pain in joints which meant that I hard time getting up and after few steps I needed to sit down. Headache started on the second day and the pain killers are not helping." Patient has not tested positive for COVID-19 since having the vaccine. Therapeutic measure was taken as a result of the event headache. Outcome of the events muscle pain/muscle soreness, fatigue, drowsiness, headache was not recovered. Outcome of the events fever and joint pain was recovering. Outcome of all the other events was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1416052 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-31
Onset:2021-06-01
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH NOT KNOWN / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Hypersensitivity, Hypoaesthesia, Nerve injury, Partial seizures, Photosensitivity reaction, Scan brain, Skin burning sensation, Tinnitus
SMQs:, Angioedema (broad), Peripheral neuropathy (broad), Systemic lupus erythematosus (broad), Convulsions (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Hearing impairment (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased; Comments: Unsure if patient has had symptoms associated with COVID-19 Not had a COVID-19 test Patient is not enrolled in clinical trial Patient is not pregnant,Patient is not currently breastfeeding
Allergies:
Diagnostic Lab Data: Test Name: Blood test; Result Unstructured Data: Test Result:Unknown; Test Name: Head scan; Result Unstructured Data: Test Result:Unknown
CDC Split Type: GBPFIZER INC2021657167

Write-up: Tinnitus; Partial seizures; Hypersensitivity; Photosensitivity; Numbness in face; Burning sensation scalp; Nerve damage; This is a spontaneous report from a contactable consumer received from the Regulatory Authority; the Regulatory Authority report number is GB-MHRA-WEBCOVID-202106060437001310-JCPHC and the Safety Report Unique Identifier is GB-MHRA-ADR 25426691. A 32-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 31May2021 (batch/lot number not known) as 1ST DOSE, SINGLE for COVID-19 immunization. The patient''s medical history included lactation decreased from an unknown date. The patient was not enrolled in clinical trial. Patient was not pregnant and not currently breastfeeding. It was unsure if patient has not had symptoms associated with COVID-19. Patient has not had a COVID-19 test. Concomitant medications were not reported. The patient experienced partial seizures, hypersensitivity, photosensitivity, numbness in face, burning sensation scalp, and nerve damage on 01Jun202; and tinnitus on 06Jun2021. Relevant investigations or tests conducted on an unspecified date included blood test and head scan, results were not reported. Outcome of the event numbness in face recovered with sequelae. Outcome of the other events has not recovered. The events were reported as serious, medically significant, disabling/incapacitating. The patient has not tested positive for COVID-19 since having the vaccine. No follow up attempts are possible; information about the batch/lot number cannot be obtained. No further information is expected.


VAERS ID: 1416079 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002332 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Dizziness, Fatigue, Injection site pain, Muscular weakness, Nausea, Pain in extremity, Peripheral swelling, Pruritus, Rash, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Cardiac failure (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Vestibular disorders (broad), Hypersensitivity (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Penicillin allergy
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased; Vomiting (Caused by Penicillin)
Allergies:
Diagnostic Lab Data: Test Date: 20210507; Test Name: COVID-19 virus test; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: itching; a week on from having the vaccine my arm is still slightly swollen at the injection site; Swollen arm; Rash over arms; Fatigue; Aching joints; Nausea; ''jelly-like'' legs; slight dizziness/Dizzy spells; Painful arm; This regulatory authority case was reported by a consumer and describes the occurrence of PRURITUS (itching), DIZZINESS (slight dizziness/Dizzy spells), PAIN IN EXTREMITY (Painful arm), PERIPHERAL SWELLING (Swollen arm) and MUSCULAR WEAKNESS (''jelly-like'' legs) in a 34-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3002332) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Lactation decreased and Vomiting (Caused by Penicillin). Concurrent medical conditions included Penicillin allergy. On 01-Jun-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Jun-2021, the patient experienced DIZZINESS (slight dizziness/Dizzy spells) (seriousness criterion medically significant), PAIN IN EXTREMITY (Painful arm) (seriousness criterion medically significant) and MUSCULAR WEAKNESS (''jelly-like'' legs) (seriousness criterion medically significant). On 02-Jun-2021, the patient experienced FATIGUE (Fatigue), ARTHRALGIA (Aching joints) and NAUSEA (Nausea). On 03-Jun-2021, the patient experienced PERIPHERAL SWELLING (Swollen arm) (seriousness criterion medically significant) and RASH (Rash over arms). On an unknown date, the patient experienced PRURITUS (itching) (seriousness criterion medically significant) and INJECTION SITE PAIN (a week on from having the vaccine my arm is still slightly swollen at the injection site). At the time of the report, PRURITUS (itching), DIZZINESS (slight dizziness/Dizzy spells), PAIN IN EXTREMITY (Painful arm), PERIPHERAL SWELLING (Swollen arm), FATIGUE (Fatigue), NAUSEA (Nausea) and INJECTION SITE PAIN (a week on from having the vaccine my arm is still slightly swollen at the injection site) was resolving, MUSCULAR WEAKNESS (''jelly-like'' legs) outcome was unknown and RASH (Rash over arms) and ARTHRALGIA (Aching joints) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-May-2021, SARS-CoV-2 test: negative Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) was unknown. Patient began to experience intermittently ''jelly-like'' legs within a few hours of having the vaccine, and this continued for several days. During the two days following vaccine she experienced fatigue, slight dizziness, aching through body, and nausea - the nausea was occasionally quite strong. She did not vomit but felt as though she might. Since the evening of having the vaccine her left arm (into which the vaccine was administered) felt incredibly sore and heavy, and this continued for about 5 days. A week on from having the vaccine my arm is still slightly swollen at the injection site, and slightly sore to the touch. She had one or two instances of mild itching at the injection site. A few days after the vaccine she noticed a light red rash on forearms, but this disappeared by the nighttime and she was not sure whether it was just a heat rash. A week passed and till having infrequent moments of nausea and dizziness, but these seem to be lessening in strength. Patient had not tested positive for COVID-19 since having the vaccine. No concomitant medication was reported. No treatment medication was reported. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1416101 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002332 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Fatigue, Influenza like illness, Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Fibromyalgia
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased; Suspected COVID-19 (Unsure when symptoms started Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: flu like symptoms; Vomiting; Tiredness; This regulatory authority case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms), VOMITING (Vomiting) and FATIGUE (Tiredness) in a 32-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3002332) for COVID-19 vaccination. The patient''s past medical history included Lactation decreased and Suspected COVID-19 (Unsure when symptoms started Unsure when symptoms stopped). Concurrent medical conditions included Fibromyalgia. On 01-Jun-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 01-Jun-2021, the patient experienced VOMITING (Vomiting) (seriousness criterion medically significant) and FATIGUE (Tiredness) (seriousness criterion medically significant). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms) (seriousness criterion medically significant). On 03-Jun-2021, VOMITING (Vomiting) had resolved. On 05-Jun-2021, FATIGUE (Tiredness) had resolved. At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms) outcome was unknown. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) was unknown. Concomitant product use was not provided by the reporter. No treatment information was provided. Patient had not tested positive for covid-19 since having the vaccine. No treatment information was provided. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1416107 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-31
Onset:2021-06-01
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002332 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Pain in extremity, SARS-CoV-2 test
SMQs:, Tendinopathies and ligament disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20201231; Test Name: COVID-19 virus test; Test Result: Positive ; Result Unstructured Data: Yes - Positive COVID-19 test; Test Name: further covid PCR test; Test Result: Negative ; Result Unstructured Data: Had a further covid PCR test and was negative
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Painful arm; This regulatory authority case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Painful arm) in a female patient of an unknown age who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3002332) for COVID-19 vaccination. The patient''s past medical history included Suspected COVID-19 from 25-Dec-2020 to 18-Jan-2021. On 31-May-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 01-Jun-2021, the patient experienced PAIN IN EXTREMITY (Painful arm) (seriousness criterion medically significant). At the time of the report, PAIN IN EXTREMITY (Painful arm) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Dec-2020, SARS-CoV-2 test: yes - positive covid-19 test (Positive) Yes - Positive COVID-19 test. On an unknown date, SARS-CoV-2 test: negative (Negative) Had a further covid PCR test and was negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No treatment information was provided. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.


VAERS ID: 1416132 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-03
Onset:2021-06-01
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Inappropriate schedule of product administration, Lymphadenopathy, Neck pain, SARS-CoV-2 test
SMQs:, Arthritis (broad), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Sleep excessive
Allergies:
Diagnostic Lab Data: Test Date: 20210513; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021666410

Write-up: swollen lymph nodes in neck; inappropriate schedule of vaccine administered/on 03Jun2021 as second dose/first dose on 13Apr2021; pain radiating up neck and down shoulder; This is a spontaneous report from a contactable consumer (patient) received from the regulatory authority. This is the second of two reports. The first report is a report downloaded from the regulatory authority with regulatory authority report number GB-MHRA-WEBCOVID-202106051345058960-5G9G0 and Safety Report Unique Identifier GB-MHRA-ADR 25425894. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiration date unknown), via an unspecified route of administration on 03Jun2021 as second dose, single for COVID-19 immunization. Medical history included sleeping a lot. The patient''s concomitant medications were not reported. Patient has not had symptoms associated with COVID-19, and she was not enrolled in clinical trial. The patient previously received the first dose of BNT162B2 (Lot number: EM4965) on 13Apr2021 for COVID-19 immunization and experienced pain and swollen lymph nodes for which she went to A&E, it (swollen lymph nodes in her neck) was visibly raised and very painful and difficult to sleep properly. The patient experienced swollen lymph nodes in neck on 04Jun2021 and pain radiating up neck and down shoulder on Jun2021, both reported as serious with seriousness criteria of other medically important condition. Additionally, the patient experienced inappropriate schedule of vaccine administered on 03Jun2021. The clinical course was reported as follows: Two days ago, the patient had her second dose of Pfizer vaccine on 03Jun2021 and since yesterday (24 hours later), the same symptoms of swollen lymph nodes in her neck. Again, she was using ibuprofen and paracetamol. The pain was radiating up her neck and down her shoulder. It was not pleasant. Patient has not tested positive for COVID-19 since having the vaccine. The patient underwent COVID-19 virus test on 13May2021 with the following result: No - Negative COVID-19 test. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1416140 (history)  
Form: Version 2.0  
Age: 59.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-06-01
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 206A21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Eye swelling, Pruritus, Rash, Rash vesicular
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: HNJNJFOC20210636116

Write-up: EYES SWOLLEN/ EYE WERE COMPLETELY SHUT; RASH DEVELOPED INTO BLISTERS (SOME OF IT); SEVERE RASH ON FACE , BOTH EYES, ON SHOULDER AND NOSE; ITCHY; This spontaneous report received from a patient concerned a 59 year old female. The patient''s weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, dose not reported and batch number: 206A21A expiry: UNKNOWN) 1 total, administered on 25-MAY-2021 to left arm as prophylactic vaccination. No concomitant medications were reported. After a week, on an unspecified date in JUN-2021, the patient had a severe rash all over the face, shoulder and nose. The eyes were swollen and rash was on both sides while, rash developed into blisters (some of it). On an unspecified date, the patient treated with a steroid shot dexamethasone 8 mg (unspecified route and frequency). The patient visited to clinic for second opinion from another doctor (as well at the second clinic) and they also recommended a cortisone shot, since eyes were completely shut. The patient also received (antihistamine) Rinport 120 mg and at night Histarax 25 mg once in a day. The patient also received prednisolone 20 mg at dinner for 3 days. The patient experienced itchy. It was reported that, patient did some yard work and may be allergic to but was not sure about it. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe rash on face, both eyes, on shoulder, and nose, eyes swollen/ eyes were completely shut, rash developed into blisters (some of it), and itchy. This report was serious (Other Medically Important Condition). Following receipt of additional information, it was determined that nullification was required for Case Number (20210612851). The information indicated that Case Number (20210612851) originated from location, and not location as previously reported. Therefore, this case 20210636116 was created to correct the location of primary source. All relevant information will be submitted under Case Number 20210636116.; Sender''s Comments: V0:20210636116-Covid-19 vaccine ad26.cov2.s-Eyes Swollen/Eyes were completely shut- This event is considered un-assessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. 20210636116-Covid Vaccine ad26.cov2.s-Rash Developed Into Blisters (some of it), Severe Rash on Face, both eyes, on shoulder and nose. This event(s) is considered related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are no other factors more likely to be associated with the event(s) than the drug.


VAERS ID: 1416225 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-05
Onset:2021-06-01
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Pyrexia, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Food allergy
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021658800

Write-up: Urticaria; pyrexia; This is a spontaneous report from a contactable pharmacist via medical information team. This pharmacist reported events for two patients; this is the first of two reports. A 71-year-old elderly female received the first dose of BNT162B2 (solution for injection; batch/lot and expiry information not provided) as a single dose via an unspecified route on 05Jun2021 for COVID-19 immunization. Relevant medical history included food allergies (allergic to natto, crab and buckwheat). There were no concomitant medications or past drug history reported. The pharmacist reported that on 06Jun2021, twenty-six hours after the vaccination, the patient experienced urticaria in the abdomen and back. On the third day, 07Jun2021 the symptoms did not disappear; fexofenadine was prescribed. The pharmacist inquired if this patient who experienced urticaria and pyrexia with the first vaccine should be inoculated with the second dose. The outcome of the event urticaria in the abdomen and back was not recovered. The outcome of the pyrexia was unknown. The pharmacist reported that there was no denying the adverse reaction of the vaccine. No follow-up attempts are possible. Information about batch number cannot be obtained.; Sender''s Comments: Based on chronological connection to the vaccine and known product safety profile, causality between events urticaria and pyrexia and BNT162B2 vaccine cannot be 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.,Linked Report(s) : JP-PFIZER INC-2021705677 PFIZER (Same reporter/product, different patient/events)


VAERS ID: 1416228 (history)  
Form: Version 2.0  
Age: 22.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA2453 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Body temperature, Rash papular, Vertigo
SMQs:, Anaphylactic reaction (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Vestibular disorders (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Seafood allergy
Allergies:
Diagnostic Lab Data: Test Date: 20210601; Test Name: Body temperature; Result Unstructured Data: Test Result:36.7 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC2021658883

Write-up: Precordial raised rash; Vertigo; Anaphylaxis; This is a spontaneous report from a contactable physician received from the Agency. Regulatory authority report number is v21111945. A 22-years-old female patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 01Jun2021 at 09:30 (Batch/Lot Number: FA2453; Expiration Date: 31Aug2021) as 1ST DOSE, SINGLE for COVID-19 immunisation. Medical history included crab allergy, and shrimp allergy. The patient''s concomitant medications were not reported. The patient was a 22-year-old female. Body temperature before vaccination was 36.7 degrees Centigrade. The patient had allergies history of crab allergy, and shrimp allergy. On 01Jun2021 at 9:30 (the day of vaccination), the patient received the first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number FA2453, Expiration date 31Aug2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On 01Jun2021 at 9:48 (18 min after the vaccination), the patient experienced Vertigo. On 01Jun2021 at 9:50 (20 min after the vaccination), the patient experienced Precordial raised rash. On 01Jun2021 at 9:53, the patient received EPIPEN for injection. On 01Jun2021 at 10:30, symptoms almost disappeared, the patient was hospitalized overnight, and was discharged the next day without any symptoms. On 01Jun2021, the patient was admitted to the hospital. On 02Jun2021, the patient leaved the hospital. Therapeutic measures were taken as a result of vertigo (vertigo), anaphylaxis (anaphylactic reaction), precordial raised rash (rash papular). On 02Jun2021, the outcome of the event was resolved. This report meets the criteria of Anaphylaxis. The reporting physician classified the event as serious and assessed that the event was related to bnt162b2. There were no other possible causes of the event such as any other diseases. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1416245 (history)  
Form: Version 2.0  
Age: 77.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY0779 / 1 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Neuropathy peripheral, Vaccination site erythema, Vaccination site hypoaesthesia, Vaccination site swelling
SMQs:, Peripheral neuropathy (narrow), Guillain-Barre syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210601; Test Name: body temperature; Result Unstructured Data: Test Result:36.8 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC2021659639

Write-up: Peripheral nerve disorder; Redness from the left forearm to the left palm (inoculation side); swelling; numbness; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21111919. The patient was a 77-year and one-month-old female. Body temperature before vaccination was 36.8 degrees Centigrade. On 01Jun2021 at16:37 (the day of vaccination), the patient received the first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number EY0779, Expiration date 31Aug2021) via an unspecified route of administration in left arm as 1ST DOSE, SINGLE (received at the age of 77-years-old) for COVID-19 immunization. Medical history and concomitant medications were not reported. On 01Jun2021 at 16:37 (after the vaccination), the patient experienced Peripheral nerve disorder. The course of the event was as follows: In 01Jun2021, the patient experienced redness, swelling and numbness from the left forearm to the left palm (inoculation side) since that night. The same symptoms were serious observed on the radial side. The symptoms preferred to be improved after oral anti-inflammatory analgesic. On 05Jun2021, the outcome of the events was recovering. The reporting physician classified the event as non-serious (The recovery in the future may also be serious. as reported). The reporting physician commented as follows: It was thought that the causality between the events and vaccination was high.


VAERS ID: 1416251 (history)  
Form: Version 2.0  
Age: 77.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX3617 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Blood pressure decreased, Blood pressure measurement, Body temperature, Oxygen saturation, Oxygen saturation decreased, Pneumonia, Pyrexia, Sputum increased, Unresponsive to stimuli, Urine output, Urine output decreased
SMQs:, Acute renal failure (broad), Anaphylactic reaction (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Chronic kidney disease (broad), Hypersensitivity (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (narrow), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dementia; Emphysema; Hypertension; Paroxysmal supraventricular tachycardia
Allergies:
Diagnostic Lab Data: Test Date: 20210601; Test Name: blood pressure; Result Unstructured Data: Test Result:decreased; Test Date: 20210601; Test Name: body temperature; Result Unstructured Data: Test Result:36.4 Centigrade; Test Date: 20210601; Test Name: oxygen saturation; Result Unstructured Data: Test Result:decreased to 88 %; Test Date: 20210601; Test Name: urine volume; Result Unstructured Data: Test Result:decreased; Test Date: 20210601; Test Name: oxygen saturation; Result Unstructured Data: Test Result:kept decreasing
CDC Split Type: JPPFIZER INC2021660929

Write-up: Anaphylaxis; no response after being called by name; respiratory secretion increased; low grade fever; oxygen saturation decreased to 88 percentage/ oxygen saturation kept decreasing; urine volume decreased; blood pressure decreased; pneumonia; This is a spontaneous report from a contactable physician received from the Agency Regulatory Authority. Regulatory authority report number is v21111972. A 77-year and 1-month-old male patient received the first dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number EX3617, Expiration date 31Aug2021) via an unspecified route of administration on 01Jun2021 at 10:30 (the day of vaccination), as a single dose for COVID-19 immunization. Medical history included dementia, hypertension, paroxysmal supraventricular tachycardia and emphysema. The patient''s family history was unknown. Concomitant medications were not reported. The patient previously took bisoprolol fumarate, clostridium butyricum (MIYA-BM), and suvorexant (BELSOMRA). Body temperature before vaccination was 36.4 degrees Centigrade on 01Jun2021. On 01Jun2021 at 12:00 (1 hour and 30 minutes after the vaccination), the patient experienced anaphylaxis, no response after being called by name, respiratory secretion increased, low grade fever, oxygen saturation decreased to 88 percentage/ oxygen saturation kept decreasing. On 01Jun2021, the patient experienced urine volume decreased, blood pressure decreased. On Jun2021, the patient experienced pneumonia. On 01Jun2021 (the day of vaccination), the patient was admitted to the hospital. The course of the events was as follows: On 01Jun2021 at 10:30 (the day of the vaccination), the patient received the first dose of the vaccine. On 01Jun2021 at noon (the day of the vaccination), the patient experienced syndromes such as no response after being called by name, respiratory secretion increased and low-grade fever, oxygen saturation decreased to 88 percentage. On 01Jun2021 (the day of the vaccination), epinephrine hydrochloride (BOSMIN) 1mg was subcutaneously injected, acetaminophen suppository 200mg was administered through anus and oxygen started to be administered at the dose of 2I/min. After that, urine volume decreased, blood pressure decreased and oxygen saturation kept decreasing, the oxygen supply was adjusted to 3I/min and rehydration was administered through peripheral blood vessels. On 01Jun2021 (the day of the vaccination), the patient was transferred to the emergency department of the hospital. On 02Jun2021 (1 day after vaccination), the situation was improved, the patient was discharged from the hospital and transferred back to the previous medical facility. The reporting physician classified the events as serious (hospitalization) and assessed that the events were related to BNT162B2. Other possible causes of the events such as any other diseases were not reported. The reporting physician commented as follows: although anaphylaxis was recovered, the complication as pneumonia was not completely recovered. The clinical outcome of anaphylaxis was resolved on 04Jun2021, and as of 04Jun2021 (3 days after the vaccination), the outcome of the remaining events was resolving.


VAERS ID: 1416276 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-05
Onset:2021-06-01
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY5420 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Atrial fibrillation, Cardiac failure, Decreased appetite, Nausea
SMQs:, Cardiac failure (narrow), Acute pancreatitis (broad), Supraventricular tachyarrhythmias (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: MEVALOTIN; HARNAL; PARIET; BAYASPIRIN; MAGMITT
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021702921

Write-up: Cardiac failure; Atrial fibrillation; Feeling queasy; inappetence; This is a spontaneous report from a contactable physician received via the Regulatory Authority. A 90-years-old male patient received BNT162B2 (COMIRNATY, Solution for injection), dose 1 intramuscular, administered in arm left on 05Jun2021 10:00 (Lot Number: EY5420; Expiration Date: 31Aug2021) as 1st dose, single for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included pravastatin sodium (MEVALOTIN), tamsulosin hydrochloride (HARNAL), rabeprazole sodium (PARIET), acetylsalicylic acid (BAYASPIRIN), and magnesium oxide (MAGMITT) within 2 weeks of vaccination. The patient previously took valsartan (DIOVAN) and experienced drug allergy. In Jun2021, the patient experienced cardiac failure, atrial fibrillation, feeling queasy, and inappetence. The events resulted in visit to clinic, life-threatening and disability. It was unknown as to whether the patient received treatment. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was unknown.; Sender''s Comments: The information available in this report is limited and does not allow a medically meaningful assessment of the case. Based on the information currently available, a causal association between the reported events and BNT162B2 cannot be fully excluded. Case will be reassessed when additional 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 RAs, Ethics Committees, and investigators, as appropriate.


VAERS ID: 1416281 (history)  
Form: Version 2.0  
Age: 86.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-31
Onset:2021-06-01
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA4597 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Depressed level of consciousness, Dyspnoea, Pyrexia, Seizure, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiac failure chronic (Under medical treatment); Chronic kidney disease (Under medical treatment)
Allergies:
Diagnostic Lab Data: Test Date: 20210531; Test Name: body temperature; Result Unstructured Data: Test Result:36.5 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC2021711217

Write-up: Round-trip convulsions for about 5 seconds; Consciousness clouding; Dyspnoea; pyrexia; Vomiting; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21114131. The patient was an 86-year-old male. Body temperature before vaccination on 31May2021 was 36.5 degrees Centigrade. The vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status) included Cardiac failure chronic and Chronic kidney disease(Under medical treatment). Concomitant medications were not reported. In the morning of 31May2021 (the day of vaccination)(as reported), the patient received the second dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number FA4597, Expiration date 31Aug2021) via an unspecified route of administration as a single dose at the age of 86-year-old for COVID-19 immunisation. The course of the event was as follows: In the morning of 01Jun2021(as reported), The patient received the second of corona vaccine. On 01Jun2021 at 23:00, the patient experienced pyrexia, dyspnoea, and vomiting. And before dawn on 02Jun2021 visited the emergency outpatient department of the hospital. At that time, he was admitted to the hospital because of Round-trip convulsions for about 5 seconds and consciousness clouding. In the morning of the same day, no pyrexia and his consciousness improved. On 02Jun2021 (2 days after the vaccination), the patient was admitted to the hospital (hospitalization from 02Jun2021 to 05Jun2021). On 05Jun2021 (5 days after the vaccination), the outcome of the event was recovering. The reporting physician classified the event as non-serious and assessed that the event was related to BNT162B2. There was no other possible cause of the event such as any other diseases. The reporting physician commented as follows: It was thought to be the vaccine side reaction.


VAERS ID: 1416621 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002332 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Pain, Pain in extremity
SMQs:, Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Pain; Painful arm; This regulatory authority case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Painful arm) and PAIN (Pain) in a 32-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3002332) for COVID-19 vaccination. The patient''s past medical history included Lactation decreased. On 01-Jun-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Jun-2021, the patient experienced PAIN IN EXTREMITY (Painful arm) (seriousness criterion medically significant). On an unknown date, the patient experienced PAIN (Pain) (seriousness criterion medically significant). The patient was treated with PARACETAMOL ongoing since an unknown date for Pain, at an unspecified dose and frequency. On 04-Jun-2021, PAIN IN EXTREMITY (Painful arm) had resolved. At the time of the report, PAIN (Pain) had resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) was unknown. No concomitant medication reported. Patient has no symptoms associated with COVID-19 and not had a COVID-19 test. The patient was not enrolled in clinical trial. The patient is not pregnant and currently not breastfeeding.The patient has not tested positive for COVID-19 since having the vaccine. Company comment Very limited information regarding this events has been provided at this time. Further information has been requested. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. On 01-Jun-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Jun-2021, the patient experienced PAIN IN EXTREMITY (Painful arm) (seriousness criterion medically significant). On an unknown date, the patient experienced PAIN (Pain) (seriousness criterion medically significant). The patient was treated with PARACETAMOL ongoing since an unknown date for Pain, at an unspecified dose and frequency. On 04-Jun-2021, PAIN IN EXTREMITY (Painful arm) had resolved. At the time of the report, PAIN (Pain) had resolved.; Sender''s Comments: Very limited information regarding this events has been provided at this time. Further information has been requested.


VAERS ID: 1416630 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-29
Onset:2021-06-01
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-06-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002332 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Hypoaesthesia, Limb discomfort, Nerve injury, Pain in extremity, Rash pruritic, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Accidents and injuries (narrow), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: The patient had not tested positive for COVID-19 since having the vaccine
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Still having pain in my lower arm; Itchy rash; Arm discomfort; Nerve damage; Numbness in hand; Hand pain; This regulatory authority case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Still having pain in my lower arm), LIMB DISCOMFORT (Arm discomfort), NERVE INJURY (Nerve damage), HYPOAESTHESIA (Numbness in hand), PAIN IN EXTREMITY (Hand pain) and RASH PRURITIC (Itchy rash) in a 37-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3002332) for COVID-19 vaccination. The patient''s past medical history included Lactation decreased. On 29-May-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 01-Jun-2021, the patient experienced LIMB DISCOMFORT (Arm discomfort) (seriousness criterion medically significant), NERVE INJURY (Nerve damage) (seriousness criterion medically significant), HYPOAESTHESIA (Numbness in hand) (seriousness criterion medically significant) and PAIN IN EXTREMITY (Hand pain) (seriousness criterion medically significant). On 06-Jun-2021, the patient experienced RASH PRURITIC (Itchy rash) (seriousness criterion medically significant). On an unknown date, the patient experienced PAIN IN EXTREMITY (Still having pain in my lower arm) (seriousness criterion medically significant). On 08-Jun-2021, RASH PRURITIC (Itchy rash) was resolving. At the time of the report, PAIN IN EXTREMITY (Still having pain in my lower arm) was resolving and LIMB DISCOMFORT (Arm discomfort), NERVE INJURY (Nerve damage), HYPOAESTHESIA (Numbness in hand) and PAIN IN EXTREMITY (Hand pain) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) The patient had not tested positive for COVID-19 since having the vaccine. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided by the reporter. The patient had severe pain in arm, hand and fingers numbness in the hand and fingers then swollen arm with itchy rash. The patient still had pain in lower arm, hand and fingers. Treatment information included have been given strong painkillers (unspecified). Company comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded


VAERS ID: 1418241 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-01
Submitted: 0000-00-00
Entered: 2021-06-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arrhythmia, Condition aggravated
SMQs:, Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Cardiac arrhythmia
Preexisting Conditions: Medical History/Concurrent Conditions: Heart disorder (Cardiodefibrilator implant)
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021676645

Write-up: arrhythmia worsened; arrhythmia worsened; This is a spontaneous report based on information received by Pfizer from Biontech [manufacturer control number: 61785], license party for Comirnaty. A contactable consumer (patient''s husband) reported that a female patient of an unspecified age received BNT162B2 (COMIRNATY), 2nd dose via an unspecified route of administration on 02Jun2021 (Batch/Lot Number: Unknown) as a single dose for covid-19 immunisation. Medical history included Heart disorder (cardiodefibrilator implant), ongoing cardiac arrhythmia. The patient''s concomitant medications were not reported. The patient previously received BNT162B2 (COMIRNATY), 1st dose via an unspecified route of administration on 08May2021 (Lot Number: Unknown) as a single dose for covid-19 immunisation. The patient experienced arrhythmia worsened in Jun2021. The outcome of the event was unknown. Clinical course: patient was suffering from cardiac arrhythmia for a long time but her symptoms got worse after the 2nd dose of Comirnaty. The 1st dose the patient had received on 08May2021 and the 2nd was last Wednesday (02.Jun2021). Since yesterday evening she had been admitted to a cardiac hospital. The patient has also since earlier a Cardiodefibrilator implanted. Information on the lot/batch number has been requested.


VAERS ID: 1418830 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Chest pain, Electrocardiogram, Heart rate, Heart rate increased, Inappropriate schedule of product administration, Palpitations, Viral infection
SMQs:, Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Medication errors (narrow), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiac disorder; Comments: Not on any medication Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test Patient is not enrolled in clinical trial
Allergies:
Diagnostic Lab Data: Test Name: blood pressure; Result Unstructured Data: Test Result:unknown results; Test Name: ECG; Result Unstructured Data: Test Result:unknown results; Test Date: 20210603; Test Name: pulse rate; Result Unstructured Data: Test Result:high
CDC Split Type: GBPFIZER INC2021663659

Write-up: inflammatory markers/Viral infection; Heart racing; Acute chest pain; High pulse rate; received first dose on 16Mar2021/second dose on 01Jun2021; This is a spontaneous report from a contactable consumer (parent) received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202106061513572520-LVPHM, Safety Report Unique Identifier GB-MHRA-ADR 25427380. A 17-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on 01Jun2021 (at the age of 17 years old) as dose 2, single for COVID-19 immunization. Medical history included hole in heart from an unknown date and unknown if ongoing. The patient was not on any medication. Patient has not had symptoms associated with COVID-19 and not had a COVID-19 test. Patient is not enrolled in clinical trial. The patient''s concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on 16Mar2021 as dose 1, single for COVID-19 immunization. The patient experienced heart racing, acute chest pain, high pulse rate on 03Jun2021 and inflammatory markers/viral infection on an unspecified date. It was reported that the reporter spoke to the doctor and the doctor asked the patient questions, he then had to attend for a serious of tests. He was given an ECG, blood pressure was taken. Test for inflammatory markers was not done. To identify if c reactive protein was found or erythrocytes sedimentation rate. The reporter doesn''t feel all tests were done as the patient had a hole in his heart when he was born, which closed at 13 weeks. The reporter assessed all events as serious (medically significant). It was also reported that the patient received first dose on 16Mar2021/second dose on 01Jun2021. Patient has not tested positive for COVID-19 since having the vaccine. The patient underwent lab tests and procedures which included blood pressure: unknown results on an unspecified date, electrocardiogram (ECG): unknown results on an unspecified date and pulse rate: high on 03Jun2021. The outcome of the events was recovering. No follow-up attempts are possible; information about batch/lot number cannot be obtained. No further information is expected.


VAERS ID: 1421681 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-06-01
Submitted: 0000-00-00
Entered: 2021-06-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 21C13-05 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Formication, Hypoaesthesia
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: DEFLAZACORT; ORFIDAL; EBASTEL FORTE FLAS; FINASTERIDE
Current Illness: Seasonal allergy
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data: Test Date: 20210607; Test Name: Blood test; Result Unstructured Data: Hemogram: HT 4.92, Hb 14.9, Ht 44.6, MCV 90.7
CDC Split Type: ESJNJFOC20210643036

Write-up: LEFT (BODY NUMBNESS); ALL THE LEFT SIDE OF THE BODY (CRAWLING SENSATION); This spontaneous report received from a consumer via a Regulatory Authority [EMEA EVHUMAN NLP, ES-AEMPS-899280] concerned a 40 year old male. The patient''s weight was 73 kilograms, and height was 173 centimeters. The patient''s concurrent conditions included seasonal allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 21C13-05 expiry: UNKNOWN) dose was not reported, 1 total administered to left arm on 01-JUN-2021 for covid-19 vaccination. Concomitant medications included finasteride (2624A) for alopecia, lorazepam (Orfidal) for insomnia, deflazacort for otalgia, ebastine (Ebastel forte) for seasonal allergy and OP3458-Otovit complex (Dietetic) 1 tablet per day, drug start period 34 (days), drug last period 7 (days), duration for drug administration was 28 days for otalgia. On 01-JUN-2021, the patient experienced left (body numbness) and all the left side of the body (crawling sensation). Other relevant diagnostics included: complete blood count (CBC): "HT" 4.92, hemoglobin (Hb) 14.9, "Hto" 44.6, mean corpuscular volume (MCV) 90.7, "HCM" 30.3, leukocytes 6.080, platelets 185.000 Coagulation: thromboplastin time (TP) 13sec, international normalized ratio (INR) 1.11, "TTPA" 33.30, Dimero D 139.0 Biochemistry: glucose (Glu) 103, Urea 41, creatinine (CR) 0.98, total proteins 7.1, total bilirubin 1.14, sodium (Na) 141, potassium (K) 4.0, chlorine (Cl) 105, calcium (Ca) 9.1, Lactate dehydrogenase (LDH) 181, creatine kinase (CK) 139, glutamic-oxaloacetic transaminase (GOT) 23, Glutamic Pyruvic Transaminase (GPT) 45, "amialsa" 49, Troponin T 5.0. On 07-JUN-2021, Laboratory data included: Blood test Hemogram: HT 4.92, Hb 14.9, hematocrit (Ht) 44.6, MCV 90.7. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from left (body numbness), and all the left side of the body (crawling sensation). report was serious (Other Medically Important Condition).; Sender''s Comments:20210643036- covid-19 vaccine ad26.cov2. s- left (body numbness), all the left side of the body (crawling sensation). This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s)


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