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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)

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VAERS ID: 1411890 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-02
   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 EX3617 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Blood pressure measurement, Blood pressure systolic increased, Body temperature, Capillary nail refill test, Heart rate, Heart rate increased, Oxygen saturation, Ventricular extrasystoles
SMQs:, Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Ventricular tachyarrhythmias (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypertension (narrow), Cardiomyopathy (broad), Hypersensitivity (narrow), Dehydration (broad), Hypokalaemia (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: Extrasystoles; Hyperlipidaemia; Hypertension
Allergies:
Diagnostic Lab Data: Test Date: 20210602; Test Name: BP; Result Unstructured Data: Test Result:158/76; Comments: at 09:58; Test Date: 20210602; Test Name: BP; Result Unstructured Data: Test Result:144/65; Comments: at 12:15; Test Date: 20210602; Test Name: Body temperature; Result Unstructured Data: Test Result:36.3 Centigrade; Comments: Before vaccination; Test Date: 20210602; Test Name: CRT; Test Result: 2 s; Comments: at 09:46; Test Date: 20210602; Test Name: HR; Result Unstructured Data: Test Result:144; Comments: at 09:46 Unit: /min; Test Date: 20210602; Test Name: HR; Result Unstructured Data: Test Result:85; Comments: at 09:58 Unit: /min; Test Date: 20210602; Test Name: P; Result Unstructured Data: Test Result:72; Comments: at 12:15; Test Date: 20210602; Test Name: SaO2; Test Result: 98 %; Comments: at 09:46 in room air; Test Date: 20210602; Test Name: SaO2; Test Result: 95 %; Comments: at 09:58 in room air; Test Date: 20210602; Test Name: SaO2; Test Result: 96 %; Comments: at 12:15 in room air
CDC Split Type: JPPFIZER INC2021653962

Write-up: BP (Blood pressure) was 158/76; Anaphylaxis; HR (heart rate) was 144 /min; premature ventricular contraction; This is a spontaneous report from a contactable physician received from the Regulatory Authority (RA). Regulatory authority report number is v21111658. A 69-year and 7-month-old female received BNT162B2 (COMIRNATY), 1st dose via an unspecified route of administration on 02Jun2021 09:26 (Lot Number: EX3617; Expiration Date: 31Aug2021) at age of 69 years old as a single dose for covid-19 immunisation. Body temperature before vaccination was 36.3 degrees Centigrade. Medical history included hypertension and hyperlipidaemia. The patient had been aware of occasional extrasystoles. The patient previously took oral theophylline (UNIPHYL) and experienced palpitations. The patient previously received influenza vaccine and experienced erythema of the skin. No information on concomitant medications was provided. The patient had no relevant family history. On 02Jun2021 at 09:46 (20 minutes after the vaccination), the patient experienced anaphylaxis and hr (heart rate) was 144 /min, premature ventricular contraction, bp (blood pressure) was 158/76 on 02Jun2021 09:58. On 02Jun2021 (the day of vaccination), the outcome of the event ''anaphylaxis and hr (heart rate) was 144 /min'' was recovered, premature ventricular contraction and bp (blood pressure) was 158/76, both was unknown. Clinical course: On 02Jun2021 at 09:46 (20 minutes after the vaccination), the patient complained of palpitations. Erythema on the entire body including the face and both arms was noted. HR (heart rate) was 144 /min, PVC (premature ventricular contraction) was noted, SaO2 (oxygen saturation percutaneous) was 98% (in room air). Breathing difficulty, wheezing or cough was not present. The patient''s consciousness was alert. CRT (capillary refilling time) was 2 seconds. On 02Jun2021 at 09:58 (32 minutes after the vaccination), generalized erythema was present. No hyperaemia eyelid was noted. The patient complained of tingling pain of the skin, and her consciousness was clear. Breathing difficulty or cough was not noted. BP (Blood pressure) was 158/76, HR was 85/min and SaO2 was 95 (in room air). Chest distress was noted. Gastrointestinal symptoms were not present. IV drip of normal saline solution, and administration of ATARAX-P 25 mg iv and GASTER 20 mg iv were performed. At 12:15 (2hours and 49 minutes after the vaccination), BP was 144/65, P (pulse rate) was 72 and SaO2 was 96% (in room air). Her symptoms stabilized. The patient returned home at her own wish. 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: Signs of anaphylaxis were confirmed, and it was considered that prompt treatment prevented the patient''s problems from aggravating, which resulted in improvement of the symptoms.


VAERS ID: 1411893 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-02
   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 EY5420 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Dyspnoea, Erythema, Pruritus
SMQs:, Anaphylactic reaction (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), 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: 20210602; Test Name: Body temperature; Result Unstructured Data: Test Result:36 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC2021653973

Write-up: pruritus; redness on R upper extremities; Dyspnoea; This is a spontaneous report from a contactable other HCP received from the Regulatory Authority (RA). Regulatory authority report number is v21111651. The patient was a 34-year and 8-month-old female. Body temperature before vaccination was 36.0 degrees Centigrade on 02Jun2021 (the day of vaccination). On 02Jun2021 at 15:05 (the day of vaccination), the patient received the second 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 02Jun2021 at 15:35 (the day of the vaccination), the patient experienced the reported events, 30 minutes after vaccination, minor dyspnoea occurred. Allegra tablet 1 tablet was taken orally. At 15:50 pruritus and redness on R upper extremities appeared. Physiological saline and Polaramine 1A and Dexart 1/2 intravenous injection treatment received. The symptoms alleviated. On 02Jun2021 (the day of the vaccination), the outcome of the event was recovering. The reporting other HCP classified the event as non-serious and assessed that the causality between the event and bnt162b2 as unassessable.


VAERS ID: 1411900 (history)  
Form: Version 2.0  
Age: 23.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-02
   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 FA5829 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Blood pressure increased, Blood pressure measurement, Body temperature, Dysphonia, Dysphoria, Heart rate, Oxygen saturation, Pruritus, Tension, Throat irritation
SMQs:, Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Parkinson-like events (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hypertension (narrow), Depression (excl suicide and self injury) (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: Fruit allergy; Irritable bowel syndrome ((stabilizer)); Menstrual irregularity ((pill)); Pollinosis; Vegetable allergy
Allergies:
Diagnostic Lab Data: Test Date: 20210602; Test Name: blood pressure; Result Unstructured Data: Test Result:181/115; Test Date: 20210602; Test Name: blood pressure; Result Unstructured Data: Test Result:172/117; Test Date: 20210602; Test Name: body temperature; Result Unstructured Data: Test Result:37 Centigrade; Comments: before vaccination; Test Date: 20210602; Test Name: pulse; Result Unstructured Data: Test Result:97; Test Date: 20210602; Test Name: pulse; Result Unstructured Data: Test Result:72; Test Date: 20210602; Test Name: oxygen saturation; Test Result: 98 %; Test Date: 20210602; Test Name: oxygen saturation; Test Result: 96 %
CDC Split Type: JPPFIZER INC2021654074

Write-up: Anaphylaxis; tension; dysphoria; rhinolalia; itching of nasal and oral mucosa; itchy throat; blood pressure 181/115; This is a spontaneous report from a contactable nurse received from the Regulatory Authority (RA). The regulatory authority report number is v21111704. The patient was 23-year-old female. Body temperature before the vaccinations was 37 degrees Centigrade. The patient had irritable bowel syndrome (Stabilizer), menstrual irregularity (pill), pollinosis, fruits and vegetable allergy as medical history. On 02Jun2021 at 13:30 (the day of vaccination), the patient received the second dose of BNT162B2(COMIRNATY Intramuscular injection, Lot number: FA5829, expiration date: 31Aug2021). Clinical course of the event was reported as follows: On 02Jun2021 at 13:50 (the day of the vaccinations), the patient experienced tension and dysphoria after vaccination and lied on bed. Then, the patient experienced rhinolalia, itching of nasal and oral mucosa, itchy throat but did not experience dyspnoea. After 15 minutes, blood pressure 181/115, P97, SpO2 98% (RA). On 02Jun2021 at 15:20, anaphylaxis was suspected. The patient was treated with bosmin intramuscular injection and the symptoms improved. Blood pressure 172/117, P72, SpO2 96%. On 02Jun2021, the patient was admitted to the hospital. As of 03Jun2021, the outcome of the events was recovered. On the same date, the patient was discharged from the hospital. The reporter classified the event as serious (hospitalization) and assessed the causality between the event and the vaccines as related. The patient received the first dose of COMIRNATY (lot number: EW4811, expiration date 31Jul2021) on 12May2021 for COVID-19 immunization. The patient was hospitalized for the events from 02Jun2021 to 03Jun2021. The patient recovered from the events on 03Jun2021.


VAERS ID: 1411908 (history)  
Form: Version 2.0  
Age: 79.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-28
Onset:2021-06-02
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-06-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY0779 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Platelet count decreased
SMQs:, Haematopoietic thrombocytopenia (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:
Preexisting Conditions: Medical History/Concurrent Conditions: Hyperlipidaemia; Hypertension; Reflux oesophagitis
Allergies:
Diagnostic Lab Data: Test Name: the blood was collected; Result Unstructured Data: Test Result:200,000; Comments: Before that, it had been around 200,000.; Test Date: 20210602; Test Name: the blood was collected; Result Unstructured Data: Test Result:49,000; Test Date: 20210603; Test Name: the blood was collected; Result Unstructured Data: Test Result:47,000
CDC Split Type: JPPFIZER INC2021654278

Write-up: that the platelets had dropped to 49,000. Before that, it had been around 200,000.; This is a spontaneous report from a contactable Physician. The patient was 79 years old female. On 28May2021, 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 a single dose for COVID-19 immunization. The patient''s medical history included Hypertension, Hyperlipidaemia, Reflux oesophagitis. The details of the reaction was reported as follow: On 28May2021, the first dose of vaccination performed. The patient often saw a doctor. Therefore, blood will be collected regularly. On 02Jun2021, after the blood was collected, it was found that the platelets had dropped to 49,000. Before that, it had been around 200,000. On 03Jun2021, conducted a review, The result was 47,000. It did not seem to be going down all the time. Therefore, this situation was now being observed. Checked through the internet, There was no record about blood. Except for vaccination, nothing else. Therefore, Physician suspected it was caused by the vaccine. Physician thought the two values of 49,000 and 47,000 are normal margins of error. Physician thought it may not continue to decrease. The Patient undergoing regular medical examinations. On 07Jun2021, the patient went to the hospital to do examination. Outcome of event was unknown. No follow up attempts are possible. No further information is expected.; Sender''s Comments: The information currently provided is too limited to make a meaningful medical assessment hence, the event is conservatively assessed as related to the suspect drug BNT162B2 until further information becomes available. This 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 to regulatory authorities, Ethics Committees, and Investigators, as appropriate.


VAERS ID: 1411913 (history)  
Form: Version 2.0  
Age: 54.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-02
   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 EW4811 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic shock, Body temperature
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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anaphylactic shock (The patient previously received a cold medicine and experienced anaphylactic shock 30 years before.)
Allergies:
Diagnostic Lab Data: Test Date: 20210602; Test Name: Body temperature; Result Unstructured Data: Test Result:36.2 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC2021654769

Write-up: Anaphylactic shock; This is a spontaneous report from a contactable physician received from the Regulatory Authority (RA). Regulatory authority report number is v21111673. The patient was a 54-year and 5-month-old female. Body temperature before vaccination was 36.2 degrees centigrade. Family history was reported as unknown. The patient previously received a cold medicine and experienced anaphylactic shock 30 years before. The patient previously received an influenza vaccine and experienced no abnormalities. Concomitant medications were not reported. On 02Jun2021 at 14:35 (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EW4811, Expiration date 31Jul2021) via an unspecified route of administration as a single dose for COVID-19 immunisation. On 02Jun2021 at 14:43 (8 minutes after the vaccination), the patient experienced anaphylaxis shock. On 02Jun2021 (the day of vaccination), the outcome of the event was recovering. The course of the event was as follows: On 02Jun2021 at 14:43 (8 minutes after the vaccination), the patient experienced respiratory discomfort, respiratory tract closed sensation of, and sweaty. Adrenaline 0.3 ml was administered intramuscularly, but the symptoms were uncontrolled; the patient was transported by ambulance. Although being carried to another hospital, the patient was not admitted and went home. Diagnosis could be anaphylaxis shock. 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: Caution was needed for the historical condition of anaphylactic shock even though the onset was 30 years before.


VAERS ID: 1411916 (history)  
Form: Version 2.0  
Age: 93.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-02
   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 FA2453 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Blood pressure decreased, Blood pressure measurement, Body temperature, Chest X-ray abnormal, Depressed level of consciousness, Oxygen saturation, Polymerase chain reaction, Pyrexia
SMQs:, Anaphylactic reaction (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (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? Yes
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Hypertension (no drug was taken)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210602; Test Name: Blood pressure; Result Unstructured Data: Test Result:166/106; Comments: 11:20; Test Date: 20210602; Test Name: Blood pressure; Result Unstructured Data: Test Result:122/89; Comments: 11:52; Test Date: 20210602; Test Name: Blood pressure; Result Unstructured Data: Test Result:110/70; Comments: 12:50; Test Date: 20210602; Test Name: Blood pressure; Result Unstructured Data: Test Result:60/; Comments: 12:59; Test Date: 20210602; Test Name: Blood pressure; Result Unstructured Data: Test Result:78/60; Comments: 13:05; Test Date: 20210602; Test Name: Blood pressure; Result Unstructured Data: Test Result:129/71; Comments: 13:35; Test Date: 20210602; Test Name: Body temperature; Result Unstructured Data: Test Result:36.4 Centigrade; Comments: before vaccination; Test Date: 20210602; Test Name: Body temperature; Result Unstructured Data: Test Result:36.4 Centigrade; Comments: 11:20; Test Date: 20210602; Test Name: Body temperature; Result Unstructured Data: Test Result:37.9 Centigrade; Comments: 11:52; Test Date: 20210602; Test Name: Body temperature; Result Unstructured Data: Test Result:38.6 Centigrade; Comments: 12:50; Test Date: 20210602; Test Name: SpO2; Test Result: 92 %; Comments: 12:50; Test Date: 20210602; Test Name: SpO2; Test Result: 98 %; Comments: 13:05; Test Date: 20210602; Test Name: SpO2; Test Result: 98 %; Comments: 13:35; Test Date: 20210602; Test Name: PCR test; Test Result: Negative
CDC Split Type: JPPFIZER INC2021655924

Write-up: Anaphylaxis; response of the questions was slow; rapid pyrexia/body temperature increased; blood pressure decreased; shadow in lung; This is a spontaneous report from a contactable physician received from the Regulatory Authority (RA). Regulatory authority report number is v21111757. The patient was a 93-year and 7-month-old male/female. Body temperature before vaccination was 36.4 degrees Centigrade. 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 had Ischemic cerebral hemorrhage(and had Plavix), and ongoing hypertension(no drug was taken). On 12May2021, the patient previously received the first dose of bnt162b2 (COMIRNATY, Lot# EY2173, Expiration date 31Aug2021). On 02Jun2021 at 11:22 (the day of vaccination), the patient received the second 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 at the age of 93-year-old. On 02Jun2021 at 12:50 (88 minutes after the vaccination), the patient experienced the following events. Clinical course of the event was reported as follows: The report about the onset of Anaphylaxis: The Symptoms onset after vaccination:1 hour and 30 minutes. It was a sudden onset, and rapid progression of signs and symptoms include rapid pyrexia and blood pressure decreased. There was cardiovascular symptoms (blood pressure decreased). There was no Gastrointestinal symptoms, Respiratory symptoms or Dermatologic/mucosal symptoms. After 1 hour and 30 minutes, the body temperature increased, blood pressure decreased were found, response of the questions was slow. Physician was notified and asked the patient lay on bed and confirmed the condition. The treatment for anaphylaxis were reported as below: Onset time was 12:57, doctor calling time was 12:58. On 12:59, Adrenaline 0.3 and Oxygen 3l/min were given. Kept the route of midline vein and fully give the normal saline. Polaramine 5mg/1ml 1A,Gaster 20mg/1A, normal saline 20ml by Intravenous injection. Solu-Cortef 500mg and normal saline 100ml 30min by IV drip. Tested the vital sign 5 minutes after Adrenaline. Adrenaline was given for the second time. Due to the blood pressure decreased, Inovan was given by Syringe pump. Due to the Respiratory symptoms, Neophyllin 250mg 1A was given, and normal saline 100ml had been given for 30 minutes. and Sultanol Inhaler2 inhaled. Did not improved after Adrenaline was given for the second time, Glucagon1mgx2A and normal saline 20ml (for more than 5 minutes) by Intravenous injection. The time course of the anaphylactic reaction were reported as below: at 11:20 blood pressure was 166/106, body temperature was 36.4. at 11:52 blood pressure was 122/89, body temperature was 37.9 at 12:50 blood pressure was 110/70, SpO2 was 92%. body temperature was 38.6.and orally received Calonal. at 12:59 blood pressure was 60/ , Bosmin 0.3 was given by Intramuscular injection.O2 3L started, ensured the route with normal saline and Linolosal 1A. at 13:05 blood pressure was 78/60, SpO2 was 98%. at 13:07 Discussed whether to call an ambulance, and decided to call if the symptoms did not improved in 30 minutes. at 13:16 Consider that uncertain things may happen during the night shift, Just in case an ambulance was called. PRIVACY hospital accepted the request. at 13:35 blood pressure was 129/71, SpO2 was 98% and ambulance arrived. On 02Jun2021 (the day of vaccination), the patient was admitted to the hospital. On 04Jun2021 at 10:30(two days after the vaccination), the patient discharged from hospital. On 04Jun2021, the outcome of the event was recovered. The reporting physician classified the event as serious (hospitalized) and assessed that the event was related to bnt162b2./ that the event was unrelated to bnt162b2.There was no other possible cause of the event such as any other diseases. The reporting physician commented as follows: Epinephrine and Steroid were given as soon as (the symptoms) were found, and symptoms improved quickly. Thought that there was no need to be hospitalized, but consider about the patient was an elderly, and the correspondence at night in the institution. Transported to hospitalization by ambulance. During the hospitalization, Negative was confirmed according to the PCR test. Since there was shadow in lung, hospitalized for several days for further precise test.


VAERS ID: 1411924 (history)  
Form: Version 2.0  
Age: 87.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-02
   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 EY2173 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Blood pressure decreased, Blood pressure measurement, Body temperature, Cold sweat, Depressed level of consciousness, Rash, Salivary hypersecretion, Vomiting
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (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: Diabetes mellitus
Preexisting Conditions: Medical History/Concurrent Conditions: Hypoglycaemia
Allergies:
Diagnostic Lab Data: Test Date: 20210602; Test Name: Body temperature; Result Unstructured Data: Test Result:36.3 Centigrade; Comments: before vaccination; Test Date: 20210602; Test Name: Blood pressure; Result Unstructured Data: Test Result:100~80; Comments: decreased
CDC Split Type: JPPFIZER INC2021656056

Write-up: Anaphylaxis; consciousness clouding that the reaction to the question was slow; salivation; vomiting; Blood pressure decreased(100~80); cold sweat; rash on hand and feet; This is a spontaneous report from a contactable physician received from the Regulatory Authority. The Regulatory authority report number is v21111706. The patient was an 87-year and 0-month-old female. Body temperature before vaccination was 36.3 degrees Centigrade. The patient''s family history was reported as nothing special. There were no points to be considered on the vaccine screening questionnaire. On 02Jun2021 at 10:30, the patient received the second dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number EY2173 Expiration date 31Aug2021) via an unspecified route of administration as a single dose for COVID-19 immunization at the age of 87-year-old. On 02Jun2021 at 10:44 (14 minutes after the vaccination), the patient experienced vomiting, blood pressure decreased, and cold sweat. On 03Jun2021(next day of vaccination), the outcome of the event was recovered. The course of the event was as follows: about 10 minutes after vaccination, the salivation started. After, the patient vomited something which seems to be the contents of the stomach, and consciousness clouding that the reaction to the question was slow. Blood pressure decreased (100/80) was confirmed, cold sweat was also appeared. Lay on bed. Ensure the IV drip route, and Solu-Cortef 250mg IV started. after minutes, the reaction was back, then rash on hand and feet appeared. The reporting physician classified the event as non-serious and assessed that the event was related to bnt162b2. Other possible causes of the event such as any other diseases were hypoglycaemia due to diabetes mellitus. The reporting physician commented as follows: On 12May2021 the patient received the first dose and there was not any adverse event, but the allergic reaction appeared for the second dose. Consider it was anaphylactic reaction.


VAERS ID: 1411941 (history)  
Form: Version 2.0  
Age: 77.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-31
Onset:2021-06-02
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-06-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA4597 / 1 RA / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Cerebral thrombosis, Dysarthria, Muscular weakness
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: ZETIA; BEZATOL; CANALIA COMBINATION
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Carotid arteriosclerosis; Diabetes mellitus; Dyslipidaemia
Allergies:
Diagnostic Lab Data: Test Date: 20210531; Test Name: body temperature; Result Unstructured Data: Test Result:36.3 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC2021656247

Write-up: Cerebral thrombosis; Inarticulateness; left hand was lazy and weak; This is a spontaneous report from a contactable Physician received from the regulatory authority. Regulatory authority report number is v21111813. A 77-year and 4-month-old male patient received first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number FA4597, Expiration date 31Aug2021) via an unspecified route of administration in the deltoid right on 31May2021 at 13:00 at age of 77 years old as a single dose for COVID-19 immunization. Medical history included diabetes mellitus, carotid arteriosclerosis and dyslipidaemia. Body temperature before vaccination was 36.3 degrees Centigrade on 31May2021. It was unknown whether the patient had family history. The patient was taking medicine orally included canagliflozin hemihydrate/teneligliptin hydrobromide (CANALIA COMBINATION, tablets), bezafibrate (BEZATOL) and ezetimibe (ZETIA). The patient did not receive other vaccination within 1 month. On 02Jun2021 (2 days after the vaccination), the patient experienced Cerebral thrombosis. On 02Jun2021 (2 days after the vaccination), the patient was admitted to the hospital. The course of the event was follows: On 31May2021 (the day of the vaccination), the patient received the COMIRNATY in the deltoid right. After 15 minutes of observation, there was no abnormality. On 02Jun2021 (2 days after the vaccination), the patient contacted the clinic and said that his left hand was lazy and weak and there was inarticulateness. An ambulance was called and the patient was send to brain surgery. On 03Jun2021 at 13:35 (3 days after the vaccination), the patient was diagnosed with Cerebral thrombosis, and admitted to the hospital for about two weeks. Outcome of the events was unknown. The reporting physician classified the event as serious (hospitalized on 02Jun2021) and assessed the causality between the event and BNT162b2 as unassessable. Other possible causes of the event such as any other diseases was Carotid arteriosclerosis. The reporting physician commented as follows: Cerebral thrombosis as a side reaction after vaccination cannot be ruled out.


VAERS ID: 1411944 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-02
   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 FA7338 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Asthma, Body temperature, Dyspnoea, Oxygen saturation, Wheezing
SMQs:, Anaphylactic reaction (narrow), Angioedema (broad), Asthma/bronchospasm (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (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? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma bronchial
Allergies:
Diagnostic Lab Data: Test Date: 20210602; Test Name: body temperature; Result Unstructured Data: Test Result:36.2 Centigrade; Comments: before vaccination; Test Date: 20210602; Test Name: Oxygen saturation; Test Result: 99 %
CDC Split Type: JPPFIZER INC2021656275

Write-up: Anaphylaxis; Asthmatic attack; Wheezing; Shoulder breathing; This is a spontaneous report from a contactable physician received from the Agency. Regulatory authority report number is v21111864. The patient was a 25-year-old female. Body temperature before vaccination was 36.2 degrees Centigrade. 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: asthma bronchial and allergy to LOXOPROFEN Na. On 02Jun2021 at 14:05 (the day of vaccination), the patient received the first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number FA7388, Expiration date 30Sep2021) at the age of 25-year-old via an unspecified route of administration as a single dose for COVID-19 immunization. Medical history and concomitant medications were unknown. On 02Jun2021 at 14:35 (30 minutes after the vaccination), the patient experienced Anaphylaxis and Asthmatic attack. The course of the event was as follows: On 02Jun2021 at 14:35 (30 minutes after the vaccination), the patient experienced Wheezing and Shoulder breathing, oxygen inhalation started immediately.(Brighton classification level 2). After inhaled 2L oxygen, SpO2 99%. According to hospital manual, intramuscular injection of 0.3mg Adrenaline, iv drip of 100mL physiological salt solution + 125mg Methylprednisolone Injection+ 20mg Famotidine Injection + 5mg d-Chlorpheniramine Maleate. At 16:45, Symptom was improved, oxygen inhalation was stopped, Asthmatic attack was improved. On 03Jun2021, the outcome of the event was recovered. The reporting physician classified the event as serious(hospitalization from 02Jun2021 to 03Jun2021) 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: 1411964 (history)  
Form: Version 2.0  
Age: 80.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-02
   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: Anaphylactic reaction, Eczema, Pruritus, Throat tightness, Vaccination site eczema
SMQs:, Anaphylactic reaction (narrow), Angioedema (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (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? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Fish allergy; Hypertension; Overactive bladder
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021657031

Write-up: Suspected anaphylaxis; Pruritus generalised; eczema on the back/opposite upper arm/neck; Vaccination site eczema; Feeling of throat being closed; This is a spontaneous report from a non-contactable physician received via COVID-19 Adverse Event Self-Reporting Solution (COVAES). The patient was a non-pregnant 80-year-old female. It was unknown whether the patient received other vaccine within 4 weeks prior to the COVID vaccine. The patient received unknown medication within 2 weeks of vaccination. It was unknown whether prior to vaccination, the patient was diagnosed with COVID-19. The patient had allergies to saury. Other medical history included hypertension and overactive bladder. On 02Jun2021 (the day of vaccination), the patient received the first single dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number unknown), at vaccination age of 80 years, intramuscular in the left arm for COVID-19 immunization. On 02Jun2021 (the day of vaccination), the patient experienced suspected anaphylaxis. From about 4 hours after vaccination, the patient experienced pruritus generalised, eczema on the back, the upper arm which was the vaccination site, the opposite upper arm and the neck. The patient had feeling of throat being closed on the night of 02Jun2021. Pruritus and eczema did not improve, so the patient visited the reporting hospital on 06Jun2021. The reporter stated the events result in doctor or other healthcare professional office/clinic visit. The outcome of the event was unknown with treatment including administration of anti-allergic drug and steroid. Since the vaccination, it was unknown whether the patient has been tested for COVID-19. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; 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 serious event anaphylaxis cannot be totally 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: 1411971 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-02
   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 FA4597 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure decreased, Body temperature, Discomfort, Dyspnoea, Erythema
SMQs:, Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (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: Hypertension
Allergies:
Diagnostic Lab Data: Test Date: 20210602; Test Name: body temperature; Result Unstructured Data: Test Result:36.8 Centigrade; Comments: before the vaccination
CDC Split Type: JPPFIZER INC2021658210

Write-up: Redness generalised; Dyspnoea; blood pressure decreased; sensation of heaviness on right arm; This is a spontaneous report from a contactable physician received from the Agency Regulatory Authority. Regulatory authority report number is v21111835. The patient was a 46-year-old male. Body temperature before the vaccination was 36.8 degrees Centigrade. Patient''s medical history and past drug 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 under disease of Hypertension, AZILVA (10), Nifedipine (10). On 02Jun2021 at 10:00 (the day of vaccination), the patient received the first dose of bnt162b2 (COMIRNATY Intramuscular injection, Lot number: FA4597, expiration date: 31Aug2021), via an unspecified route of administration, at the age of 46-year-old, at single dose for COVID-19 immunisation. On 02Jun2021 at 15:00, the patient experienced redness generalised, dyspnoea, blood pressure decreased, when vaccination, the patient experienced sensation of heaviness on right arm. Seriousness of the events were not provided but seriousness criteria of Medically Significant was provided. The reporter assessed the causality between the event and the vaccine as unassessable. On 02Jun2021 (same day of vaccination), the outcome of the events was recovered.


VAERS ID: 1411972 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-02
   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 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure decreased, Blood pressure measurement, Body temperature, Dysphoria, Heart rate, Lip discolouration, Oxygen saturation, Oxygen saturation decreased, Pallor, Presyncope, Respiratory rate, Speech disorder
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Acute central respiratory depression (broad), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Depression (excl suicide and self injury) (narrow), Hypotonic-hyporesponsive episode (broad), Respiratory failure (broad), Hypoglycaemia (broad), Infective pneumonia (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: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data: Test Date: 20210602; Test Name: blood pressure; Result Unstructured Data: Test Result:91/36 mmHg; Comments: at 14:10; Test Date: 20210602; Test Name: blood pressure; Result Unstructured Data: Test Result:110 mmHg; Comments: 30 mins after rehydration; Test Date: 20210602; Test Name: body temperature; Result Unstructured Data: Test Result:36.4 Centigrade; Comments: before vaccination; Test Date: 20210602; Test Name: PR; Result Unstructured Data: Test Result:60; Comments: at 14:10; Test Date: 20210602; Test Name: PR; Result Unstructured Data: Test Result:60; Comments: 30 mins after rehydration; Test Date: 20210602; Test Name: spo2; Test Result: 88 %; Comments: at 14:10; Test Date: 20210602; Test Name: spo2; Test Result: 95 %; Comments: 30 mins after rehydration; Test Date: 20210602; Test Name: RR; Result Unstructured Data: Test Result:16; Comments: 30 mins after rehydration
CDC Split Type: JPPFIZER INC2021658213

Write-up: Vasovagal reaction; Dysphoria; Pallor facial/ abnormal color in lips; Pallor facial/ abnormal color in lips; could not speak fully; blood pressure 91/36mmHg; SPO2 88%.; This is a spontaneous report from a contactable physician received from the Agency. Regulatory authority report number is v21111812. The patient was an 85-year 4-month-old male. Body temperature before vaccination was 36.4 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, etc). Concomitant medications were not reported. On 02Jun2021 at 13:10, the patient received the second dose of bnt162b2 (COMIRNATY intramuscular injection, Lot# FA5765, expiration date 30Sep2021) via an unspecified route of administration as single dose for COVID-19 immunization. On 02Jun2021 at 14:10 (1 hour after vaccination), the patient experienced Vasovagal reaction. On 02Jun2021 (the day of the vaccination), the outcome of events was recovered. The course of the event was as follows: About 1 hour after receiving bnt162b2 intramuscular injection, the patient''s chief complains included dysphoria. The patient had pallor facial and abnormal color in lips. The patient was lied and the leg was left up. Blood pressure 91/36mmHg, PR60, SPO2 88%. The patient had consciousness but could not speak fully. There was no wheeze or skin symptoms. The intravenous route was kept and Rehydration by normal saline 500ml was performed. 30 mins after rehydration, blood pressure was 110mmHg, spo2 95%, PR60, RR16, the color in face and lips recovered somewhat and the consciousness gradually clear. The reporter classified the events as non-serious. The causality between the event and bnt162b2 was not provided. There was no other possible cause of the event such as any other diseases.


VAERS ID: 1411973 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-02
   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: Body temperature, Cerebral infarction, Immobile, Infarction, Magnetic resonance imaging
SMQs:, Myocardial infarction (broad), 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? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: BAYASPIRIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cerebral infarction; Hemiparesis (left); Hypertension
Allergies:
Diagnostic Lab Data: Test Date: 20210601; Test Name: body temperature; Result Unstructured Data: Test Result:36.5 Centigrade; Comments: before vaccination; Test Date: 20210603; Test Name: MRI; Result Unstructured Data: Test Result:New Infarction; Comments: New Infarction in deep white matter of right prefrontal lobe
CDC Split Type: JPPFIZER INC2021658215

Write-up: relapse of previous history of Cerebral infarction; New Infarction in deep white matter of right prefrontal lobe; the patient sat on sofa and could no move his feet; This is a spontaneous report from a contactable physician received from the RA. Regulatory authority report number is v21111857. The patient was an 87-year and 4-month-old male. Body temperature before vaccination was 36.5 degrees centigrade. There were 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): Sequel of Cerebral infarction. Hypertension. Now taking Bayaspirin orally. On 01Jun2021 at 09:10 (the day of vaccination), the patient received the first dose of bnt162b2 (COMIRNATY Intramuscular injection, Lot number EX3617, Expiration date 31Aug2021) via an unspecified route of administration as a single dose for COVID-19 immunization. The adverse event onset date was reported as on 02Jun2021 (1 day after the vaccination). On 03Jun2021 (2 days after the vaccination), the patient was admitted to the hospital. The outcome of the event was not provided. The course of the event was as follows: The patient had Hemiparesis (left) due to original sequel of Cerebral infarction (Right pay off crown). But the patient could walk, ADL self standing. On 01Jun2021, the patient received vaccination. On the second day on 02Jun, in the afternoon, the patient sat on sofa and could no move his feet. After sliding down, the patient still could not move. The patient could not eat. On 03Jun2021, the patient could move a little bit. The patient went to see doctor on wheelchair. MRI investigation found New Infarction in deep white matter of right prefrontal lobe. The reporter classified the event as serious (hospitalization from 03Jun2021) and assessed that the causality between the event and bnt162b2 as unassessable. Other possible cause(s) of the event such as any other diseases was relapse of previous history of Cerebral infarction.


VAERS ID: 1411991 (history)  
Form: Version 2.0  
Age: 76.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-02
   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 EY0779 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Chest discomfort, Heart rate, Palpitations, Somatic symptom disorder, Urticaria, Vital signs measurement
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Arrhythmia related investigations, signs and symptoms (broad), Anaphylactic/anaphylactoid shock conditions (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 Name: pulse; Result Unstructured Data: Test Result:no arrhythmia found; Test Name: vital signs; Result Unstructured Data: Test Result:no problem
CDC Split Type: JPPFIZER INC2021658831

Write-up: Anaphylaxis; Urticaria on both hands; palpitations/mild Palpitations; Psychogenic diseases; Chest distressed feeling of; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21111915. The patient was 76-year-old female. On 01Jun2021 at 15:15 (the day of vaccinations) (at age of 76-year-old), the patient received the first dose of bnt162b2 (COMIRNATY, Intramuscular injection, Lot number: EY0779, expiration date: 31Aug2021). And the event onset date was reported as 02Jun2021 at 18:00. Clinical course of the event was reported as follows: On 01Jun2021 at 15:15 (the day of vaccinations), vaccination performed. On 02Jun2021 at 18:00 (1 day after vaccinations), the patient experienced Urticaria on both hands and palpitations appeared in the evening, but there was no itching sensation. On 03Jun2021 (2 days after vaccinations), when the patient got up on the third day, the patient complained urticaria disappeared, but still mild palpitations. There was no obvious arrhythmia. Although the causality was unknown, the possibility of Psychogenic diseases was very high. On 03Jun2021 (2 days after vaccinations), the outcome of the events was recovering. The event term was reported as urticaria, chest distressed feeling of, palpitations. The symptom was reported as Anaphylaxis. The reporter classified the event as non-serious and assessed the causality between the event and the vaccines as unassessable. Other possible cause of the event such as any other diseases was Psychogenic. The reporter''s comments: The causal relationship between urticaria and vaccination was unknown (because symptoms appeared one day after vaccination). The only symptoms were palpitations, Chest distressed feeling of, no problem with vital signs, and no arrhythmia found during pulse diagnosis, so it was judged to be a psychogenic disease.; Reporter''s Comments: The causal relationship between urticaria and vaccination was unknown (because symptoms appeared one day after vaccination). The only symptoms were palpitations, Chest distressed feeling of, no problem with vital signs, and no arrhythmia found during pulse diagnosis, so it was judged to be a psychogenic disease.


VAERS ID: 1411997 (history)  
Form: Version 2.0  
Age: 70.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-02
   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 UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Dyspnoea, Pulmonary embolism
SMQs:, Anaphylactic reaction (broad), Embolic and thrombotic events, venous (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (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: Dyslipidaemia; Hypertension; Rheumatoid arthritis
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021658941

Write-up: Pulmonary embolism; Shortness of breath; This is a spontaneous report received from a contactable physician via Pfizer sales representative. A 70-year and 1-month-old female patient received the BNT162B2 (COMIRNATY, intramuscular injection, Lot number: unknown, Expiration date: unknown) via an unspecified route of administration on 01Jun2021 (at the age of 70-year-old) as single dose for COVID-19 immunisation. The patient''s medical history included hypertension, dyslipidaemia, rheumatoid arthritis. On 02Jun2021, Shortness of breath appeared during exercise. On 05Jun2021, Pulmonary embolism was confirmed during the proximal inspection and echo inspection. On 05Jun2021, the patient was transferred to the specialized institution Center (Hospitalization). Due to today''s situation, measures were taken. This event was found after using the product. The outcome of the events was unknown.; 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 Pulmonary embolism and Shortness of breath cannot be excluded. The case will be reassessed if additional information becomes 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: 1412005 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-02
   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 ER9480 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Headache, Hyperpyrexia, Malaise, Pyrexia, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (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: DUPHASTON
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Egg allergy
Allergies:
Diagnostic Lab Data: Test Date: 20210601; Test Name: body temperature; Result Unstructured Data: Test Result:35.7 Centigrade; Comments: before vaccination; Test Date: 20210602; Test Name: body temperature; Result Unstructured Data: Test Result:38-39 Centigrade; Comments: 03:00; Test Date: 20210602; Test Name: body temperature; Result Unstructured Data: Test Result:42 Centigrade; Comments: 12:00; Test Date: 20210603; Test Name: body temperature; Result Unstructured Data: Test Result:38 Centigrade; Comments: 18:00; Test Date: 20210604; Test Name: body temperature; Result Unstructured Data: Test Result:37s Centigrade
CDC Split Type: JPPFIZER INC2021659256

Write-up: headache; malaise; vomiting; body temperature was 42 degree centigrade; pyrexia/low grade fever; This is a spontaneous report from a contactable physician received from the Regulatory Equipment. Regulatory authority report number is v21111871. The patient was a 25-year and 2-month-old female. Body temperature before vaccination was 35.7 degrees Centigrade. 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 that the patient had egg ellergy, Historical vaccine included anaphylaxis to influenza vaccine for immunization. Ongoing concomitant drug included orally taking dydrogesterone (DUPHASTON). On 01Jun2021, at age of 25-year-old, the patient received the second dose of bnt162b2 (COMIRNATY, Lot# ER9480, Expiration date 31Jul2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On 02Jun2021(one day after the vaccination), the patient experienced the following events. Clinical course of the event was reported as follows: On 01Jun2021(the day of vaccination), No symptom such as allergies was shown after vaccination. On 02Jun2021at 03:00(next day of vaccination) , body temperature was 38-39 degree centigrade,pyrexia. On 02Jun2021at 12:00 (next day of vaccination), body temperature was 42 degree centigrade. On 02Jun2021at 15:00(next day of vaccination) , vomiting appeared. On 03Jun2021 in the morning(two days after vaccination) , low grade fever, and vomiting occurred. On 03Jun2021 at 18:00(two days after vaccination), body temperature 38 degree centigrade. On 04Jun2021(three days after vaccination), body temperature was 37s degree centigrade, and there were headache and malaise. On 04Jun2021 (three days after the vaccination), the outcome of the events 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: 1412009 (history)  
Form: Version 2.0  
Age: 84.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-31
Onset:2021-06-02
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-06-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX3617 / 2 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Herpes zoster, Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021659344

Write-up: the appearance of suspected Herpes zoster was found; Skin eruption on the inoculated forearm; This is a spontaneous report from a contactable physician received from the Agency Regulatory Authority. Regulatory authority report number is v21111833. An 84-year female patient received the second dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number EX3617, Expiration date 31Aug2021) via an unspecified route of administration on 31May2021 at 20:00 (the day of vaccination) as a single dose (at 84 years old) for COVID-19 immunization. Body temperature before vaccination was not reported. 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 02Jun2021 at about 16:00 (2 days after the vaccination), the patient experienced skin eruption on the inoculated forearm. The outcome of the event was not reported. The course of the event was as follows: About 48 hours after the second vaccination of COVID-19 on the left arm, skin eruption occurred. Through visual inspection, the appearance of suspected herpes zoster was found. Antibody was being confirmed by blood collection. The reporting physician classified the event as non-serious and assessed that the causality between the event and bnt162b2 as unassessable. Other possible cause of the event such as any other diseases was reported: Herpes zoster.


VAERS ID: 1412021 (history)  
Form: Version 2.0  
Age: 90.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-02
   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 / UNK - / -

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? Yes
Birth Defect? No
Died? No
Permanent Disability? Yes
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 INC2021672440

Write-up: Cerebral infarction; This is a spontaneous report from a contactable physician. A 90-year-old female patient received bnt162b2 (COMIRNATY; Lot Number: EX3617; Expiration Date: 31Aug2021), via an unspecified route of administration on 01Jun2021 at a single dose for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 02Jun2021, the patient experienced cerebral infarction, which was medically significant, required hospitalization from 02Jun2021 to an unknown date, and was serious for disability and life threatening. The clinical course was as follows: on 01Jun2021 (the day of the vaccination), the patient received a dose of BNT162b2. On 02Jun2021 (one day after the vaccination), the patient experienced cerebral infarction. In the early morning, extensive cerebral infarction developed. Immediately, the patient was admitted to the hospital. As of this date, the patient was still being hospitalized. The clinical outcome of the event was unknown. The reporting physician classified the event as serious (life-threatening, disability, medically significant). The causality between the event and BNT162b2 was not provided.; Sender''s Comments: Based on the information provided by the reporter, it appears unlikely that subject vaccine contributed to the event of cerebral infarction. The reported event likely represent intercurrent medical condition this elderly 90 year old patient. There is limited information provided in this report. This case will be reassessed upon receipt of follow-up 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: 1412133 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal pain upper, Asthenia, Balance disorder, Dizziness, Eructation, Fear, Feeling of body temperature change, Headache, Insomnia, Loss of personal independence in daily activities, Myalgia, Nausea, Neck pain, Pyrexia, Vaccination complication, Vomiting
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Arthritis (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: Comments: No medical history was provided by the reporter.
Allergies:
Diagnostic Lab Data:
CDC Split Type: PTMODERNATX, INC.MOD20212

Write-up: "I''m very scared to take the second dose"; very unwell, almost having an accident/"don''t feel well"/"I''m still not fine"; "stomach now hurts"; "a lot of burping"; felt cold and then felt hot; "had no strength in my body"/"don''t have the strength to lead a normal life"; "high fevers from 39.5? to 40?C"; "very strong headaches"/stings in the head/"head was buzzing"/"slight headaches - not as bad as those two days"; "vomiting"; "nausea"; "was in bed with pain in the body; "was seeing everything around spinning"/a dizzy head; "doing things at home with great difficulty"/hampering my work; "unbalanced"; "stings in the head and back of the neck"; "I could not sleep"; This spontaneous case was reported by a consumer and describes the occurrence of FEAR ("I''m very scared to take the second dose"), DIZZINESS ("was seeing everything around spinning"/a dizzy head), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES ("doing things at home with great difficulty"/hampering my work), BALANCE DISORDER ("unbalanced"), NECK PAIN ("stings in the head and back of the neck"), INSOMNIA ("I could not sleep"), ASTHENIA ("had no strength in my body"/"don''t have the strength to lead a normal life"), ABDOMINAL PAIN UPPER ("stomach now hurts"), ERUCTATION ("a lot of burping"), FEELING OF BODY TEMPERATURE CHANGE (felt cold and then felt hot), VACCINATION COMPLICATION (very unwell, almost having an accident/"don''t feel well"/"I''m still not fine"), PYREXIA ("high fevers from 39.5? to 40?C"), HEADACHE ("very strong headaches"/stings in the head/"head was buzzing"/"slight headaches - not as bad as those two days"), VOMITING ("vomiting"), NAUSEA ("nausea") and MYALGIA ("was in bed with pain in the body) in a 55-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. No medical history was provided by the reporter. On 02-Jun-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 02-Jun-2021, the patient experienced DIZZINESS ("was seeing everything around spinning"/a dizzy head), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES ("doing things at home with great difficulty"/hampering my work), BALANCE DISORDER ("unbalanced"), NECK PAIN ("stings in the head and back of the neck"), INSOMNIA ("I could not sleep"), HEADACHE ("very strong headaches"/stings in the head/"head was buzzing"/"slight headaches - not as bad as those two days"), VOMITING ("vomiting"), NAUSEA ("nausea") and MYALGIA ("was in bed with pain in the body). On 03-Jun-2021, the patient experienced ASTHENIA ("had no strength in my body"/"don''t have the strength to lead a normal life"), FEELING OF BODY TEMPERATURE CHANGE (felt cold and then felt hot) and PYREXIA ("high fevers from 39.5? to 40?C"). On an unknown date, the patient experienced FEAR ("I''m very scared to take the second dose"), ABDOMINAL PAIN UPPER ("stomach now hurts"), ERUCTATION ("a lot of burping") and VACCINATION COMPLICATION (very unwell, almost having an accident/"don''t feel well"/"I''m still not fine"). The patient was treated with LEVOFLOXACIN at a dose of 500 mg; PARACETAMOL at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. On 03-Jun-2021, HEADACHE ("very strong headaches"/stings in the head/"head was buzzing"/"slight headaches - not as bad as those two days") outcome was unknown. At the time of the report, FEAR ("I''m very scared to take the second dose"), DIZZINESS ("was seeing everything around spinning"/a dizzy head), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES ("doing things at home with great difficulty"/hampering my work), BALANCE DISORDER ("unbalanced"), INSOMNIA ("I could not sleep"), ASTHENIA ("had no strength in my body"/"don''t have the strength to lead a normal life"), ABDOMINAL PAIN UPPER ("stomach now hurts"), ERUCTATION ("a lot of burping"), VACCINATION COMPLICATION (very unwell, almost having an accident/"don''t feel well"/"I''m still not fine"), PYREXIA ("high fevers from 39.5? to 40?C"), VOMITING ("vomiting"), NAUSEA ("nausea") and MYALGIA ("was in bed with pain in the body) outcome was unknown. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. Concomitant medications were not reported. Treatment medications included Nolotil and Farmoz. Company 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. However, the events doesn?t seem to be serious by medical judgement, but the events should be upgraded to serious as per SD Authority reporting."; 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. However, the events doesn?t seem to be serious by medical judgement, but the events should be upgraded to serious as per SD Authority reporting."


VAERS ID: 1412176 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-02
   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: Contusion, Fatigue, Feeling abnormal, Haematoma, Hypersomnia, Investigation, Oropharyngeal pain, Pain, Rhinorrhoea
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Dementia (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Depression (excl suicide and self injury) (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:
Allergies:
Diagnostic Lab Data: Test Name: blood values; Result Unstructured Data: Test Result:normal
CDC Split Type: SEPFIZER INC2021669973

Write-up: 3-4 large hematomas; bleedings under skin, bruises, 6 in different places; slept for 2 days; intense tiredness so she could hardly manage to open the mouth and answer the phone; It was as if she was drugged.; Pain in throat; Pain in the body; runny nose; This is a spontaneous report from a contactable physician reporting about her daughter. A 46-year-old female patient received bnt162b2 (COMIRNATY PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: was not reported), via an unspecified route of administration on 02Jun2021 at 1st dose, single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that patient experienced intense tiredness so she could hardly manage to open the mouth and answer the phone 36 hours, after the vaccination, it was as if she was drugged, pain in throat, pain in the body and runny nose on 02Jun2021 also 3-4 large hematomas and bleedings under skin, bruises, 6 in different places on an unspecified date. The reporter reported that the patient felt quite bad following the vaccination, slept for 2 days and had got large bruises on the fold of the knee and on the back. They were large like the palm of the hand and she had 6 of them and she visited the emergency unit due to the events. The patient underwent lab tests and procedures which included went to the emergency ward to have her blood values checked and they were normal. The outcome of the events intense tiredness so she could hardly manage to open the mouth and answer the phone 36 hours, after the vaccination, it was as if she was drugged and pain in throat was reported as resolved on an unspecified date in 2021, the outcome of the events 3-4 large hematomas and bleedings under skin, bruises, 6 in different places was reported as not resolved and the outcome of the events pain in the body and runny nose was reported as unknown. The batch/lot number was not provided and will be requested during follow up.; Sender''s Comments: Based on the information provided, the causal association between the suspect drug and the events 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: 1414843 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-30
Onset:2021-06-02
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Appendicitis
SMQs:

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? Yes, 4 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CAPFIZER INC2021664830

Write-up: Inflamed appendix; This is a spontaneous report from a contactable consumer (patient) via Medical Information. A 24-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 intramuscular, administered in Arm Left on 30May2021 (Batch/Lot Number: Unknown) as DOSE 1, SINGLE for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. It was unknown if the patient was pregnant. The patient experienced inflamed appendix (hospitalization, medically significant) on 02Jun2021 at 15:00. The patient was hospitalized for inflamed appendix for 4 days. Therapeutic measures were taken as a result of inflamed appendix. The event was resolving. The event required Emergency Room Visit and Physician Office Visit.


VAERS ID: 1414845 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-02
   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 EW0216 / 2 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Angina pectoris, Arthralgia, Chest pain, Myocarditis
SMQs:, Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Other ischaemic heart disease (narrow), Arthritis (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? 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, Comment: Past drug none
Allergies:
Diagnostic Lab Data:
CDC Split Type: CAPFIZER INC2021665700

Write-up: myocarditis; feeling heart and chest pain; feeling heart and chest pain; joint pain; This is a spontaneous report from a contactable consumer (patient) via Regulatory Authority. A 37-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the left arm, on 01Jun2021 17:00 (batch/lot number: EW0216), as 2nd dose, single, at age 37 years old, for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. Medical history and past drug were reported as none. Concomitant meditcations were not reported. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 post vaccination. Historical vaccine included the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), on 11May2021, as 1st dose, single, at age 37 years old, for COVID-19 immunisation. On 02Jun2021 05:00, after the first 12 hours, the patient started feeling joint pain. On 02Jun2021 17:00, after the first 24 hours (also reported as 02Jun2021 20:00), the patient started feeling heart and chest pain which lasted almost until 48 hours after the shot was administered. On 02Jun2021 20:00, the patient experienced myocarditis. The patient reported that even though she feels fine now, she sometimes feels pain in the chest area. The patient worries about the lasting adverse effects of the myocarditis. The patient recovered from myocarditis and cardiac pain on 04Jun2021; and was recovering from chest pain and joint pain. Information about the batch number has been requested.


VAERS ID: 1415600 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-02
   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: Eye pruritus, Eye swelling, Pruritus, Swelling of eyelid, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Periorbital and eyelid 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? 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 INC2021662173

Write-up: itchy eyes; eyes swollen; itchy; hives; eyes become extremely; swollen underneath and on top lid; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority-WEB, regulatory authority number GB-MHRA-WEBCOVID-202106021502037310-3JYCW. A 24-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via unspecified route of administration on 02Jun2021 11:00 (batch/lot number and expiry date unknown) at 24 years of age as 1st dose, single 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, not had a COVID-19 test, was not enrolled in clinical trial. On 02Jun2021, the patient experienced itchy eyes, eyes swollen, itchy, hives. The reporter informed that the patient received 1st dose of vaccine at around 11:00 am ad there was no noticeable impact during 15-minute observational period. The reporter informed that about an hour later eyes become extremely itchy and swollen underneath and on top lid; itchiness also on stomach and ribcage with small hives. The events itchy eyes, eyes swollen, itchy, hives were reported serious as other medically important condition. The outcome of the events itchy eyes, eyes swollen was recovering, while unknown for the rest of the events. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1415605 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-02
   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 RA / -

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Haemorrhage, Petechiae, Rash, SARS-CoV-2 test, Skin haemorrhage
SMQs:, Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hypersensitivity (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? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: IBUPROFEN; MARVELON
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Contraception; Flushing; Foot fracture; Immunodeficiency (Has an illness or condition, not listed above, which reduces the immune response); Redness (Spots treated with Soolantra in 2020, mostly gone. Flushing and constant redness remained); Rosacea (Sub-type 1 and 2 rosacea.)
Allergies:
Diagnostic Lab Data: Test Name: Blood test; Result Unstructured Data: Test Result:Full blood screen taken, all returned OK; Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC2021657957

Write-up: Skin bleeding; Red/ purple/ brown dots/ burst blood vessels; skin rash; Petechiae; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202106031118517320-Y2MYH, Safety Report Unique Identifier GB-MHRA-ADR 25411797. A 28-year-old female patient received first dose, dose 1 via an unspecified route of administration, administered in arm right on 01Jun2021 18:00 (Lot Number: EW3143) as 1st dose, single for covid-19 immunisation. Medical history included rosacea(Sub-type 1 and 2 rosacea), erythema (Spots treated with Soolantra in 2020, mostly gone), Flushing and constant redness remained , Flushing usually connected to food items, occasionally from sun exposure, managed through daily application of SPF50, immunodeficiency (Had an illness or condition, not listed above, which reduces the immune response), foot fracture, contraception. Concomitant medications included ibuprofen taken for foot fracture from 15May2021 to 31May2021; desogestrel, ethinylestradiol (MARVELON) taken for contraception from 01Jan2015 to an unspecified stop date. 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 previously took ivermectin(SOOLANTRA) from2020 for papule. The patient experienced skin rash on 02Jun2021 08:30 with outcome of unknown , Skin bleeding on an unspecified date with outcome of unknown , petechiae on 02Jun2021 with outcome of not recovered , red/ purple/ brown dots/ burst blood vessels on an unspecified date with outcome of unknown. All events were assessed as medically significant, hospitalization and physician office visit needed. Lab data included blood test: full blood screen taken, all returned ok , COVID-19 virus test: negative, both on unknown date. The clinical course was reported as follows: Skin rash - petechiae / skin eruption on opposite arm to the vaccine site. From shoulder to wrist, front and back of the arm. Red/ purple/ brown dots/ burst blood vessels. Not raised, not dry, not itchy. Vaccine given on right arm approximately 6pm on 1st June, rash noticed on left arm at 08:30am on 2nd June, admitted to accident & emergency upon recommendation of general practitioner at 13:00 on 2nd June for blood tests. Marks still present on whole of left arm on 3rd June. Patient had not tested positive for COVID-19 since having the vaccine. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1415630 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-20
Onset:2021-06-02
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH PFIZER ET8885 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Muscle spasms, SARS-CoV-2 test
SMQs:, Dystonia (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: FEMOSTON; FLUOXETIN; INDAPAMIDE; LOSARTAN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Blood pH high; Lactation decreased; Menopause; Mental disability; Steroid therapy (Taking regular steroid treatment (e.g. orally or rectally))
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021657562

Write-up: Cramps leg; This is a spontaneous report from a contactable consumer received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202106040951078340-4FBP1 , Safety Report Unique Identifier GB-MHRA-ADR 25418971.A 53-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) , via an unspecified route of administration on 20May2021 (Lot Number: PFIZER ET8885) as SINGLE DOSE for COVID-19 immunisation.Medical history included Lactation decreased from an unknown date and unknown if ongoing, steroid therapy from an unknown date and unknown if ongoing Taking regular steroid treatment (e.g. orally or rectally), menopause from an unknown date and unknown if ongoing, mental disability from an unknown date and unknown if ongoing, blood ph increased from an unknown date and unknown if ongoing , 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(s) included dydrogesterone, estradiol (FEMOSTON) taken for menopause, start and stop date were not reported; fluoxetine hydrochloride (FLUOXETIN) taken for mental disability, start and stop date were not reported; indapamide taken for blood ph increased, start and stop date were not reported; losartan taken for blood ph increased, start and stop date were not reported. The patient experienced cramps leg on 02Jun2021 with outcome of not recovered.The patient underwent lab tests and procedures which included sars-cov-2 test: negative on an unspecified date No - Negative COVID-19 test. Additional information : Patient has not tested positive for COVID-19 since having the vaccine. The event was marked as medically significant. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1415648 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-27
Onset:2021-06-02
   Days after vaccination:6
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: Haemorrhage, Postmenopausal 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: Postmenopause (+5 years)
Preexisting Conditions: Medical History/Concurrent Conditions: Blood pressure high (Take half pill of Ibesartan a day for high Blood pressure.)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021657661

Write-up: Post Menopausal Woman/post menopausal woman with period bleeding; Bleeding; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202106041147569390-PDRGJ), Safety Report Unique Identifier GB-MHRA-ADR 25423123. A 60-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 27May2021 (Lot number was not reported) at single dose For COVID-19 immunization. Medical history included high blood pressure and took half pill of Ibesartan a day for high blood pressure, the patient is a post menopausal woman for more than 5 years. It was unsure if patient had symptoms associated with COVID-19, the patient did not have a COVID-19 test. Patient is not enrolled in clinical trial. Historical Vaccine included first dose of BNT162B2 on 06May2021 for COVID-19 immunization. The patient''s concomitant medications were not reported. The patient experienced postmenopausal bleeding on an unspecified date and bleeding on 02Jun2021. It was reported the post menopausal woman (more than 5 years) with period bleeding. The events were serious for being medical significant. The outcome of the postmenopausal bleeding was unknown, the outcome of bleeding was not resolved. Patient had not been tested positive for COVID-19 since having the Vaccine. No follow-up attempts are possible. Information about batch number cannot be obtained. No further information is expected.


VAERS ID: 1415746 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-02
   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: Abdominal pain upper, Decreased appetite, Diarrhoea, Fatigue, Headache, Vaccination site pain, Vomiting
SMQs:, Acute pancreatitis (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (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: Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021657802

Write-up: no appetite; Stomach pain/stomach cramps; Headache; Vomiting; Diarrhea; Fatigue extreme; Pain injection site; 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-202106041556232380-SL8EO, Safety Report Unique Identifier GB-MHRA-ADR 25421716. A 30-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 02Jun2021 (Lot number was not reported, at age of 30-year-old) as single dose for COVID-19 immunization. Medical history included suppressed lactation. 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. The patient''s concomitant medications were not reported. The patient experienced stomach pain on 03Jun2021, pain injection site on 02Jun2021. Got her injection in the morning on 02Jun2021, by 6pm she was extremely fatigued and vomiting/diarrhoea started at 11pm. The following day (03Jun2021) this continued and didn''t have the energy to sit up. This is accompanied by stomach cramps and a headache on 03Jun2021. Day 2 after vaccination (04Jun2021) the vomiting stopped but still no appetite. Patient has not tested positive for COVID-19 since having the vaccine. The outcome of events was recovering. The seriousness was reported as medically significant. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1415763 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-02
   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: Chills, Headache, Nausea, Pain in extremity, SARS-CoV-2 test, Thirst
SMQs:, Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Tendinopathies and ligament disorders (broad), Dehydration (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: ANADIN EXTRA
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative
CDC Split Type: GBPFIZER INC2021657693

Write-up: Headache; Nausea; Chills; Increased thirst; Painful arm; This is a spontaneous report from a contactable consumer received from a regulatory authority. A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 02Jun2021 (Lot number was not reported) as 2ND DOSE, SINGLE for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included acetylsalicylic acid, caffeine, paracetamol (ANADIN EXTRA) taken for an unspecified indication, start and stop date were not reported. Historical vaccine was taken for first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 12May2021 (Lot number was not reported) for covid-19 immunisation and experienced painful arm. The patient experienced painful arm on 02Jun2021 with outcome of recovering, headache and nausea and chills all on 03Jun2021 with outcome of recovered on 03Jun2021, increased thirst on 02Jun2021 with outcome of recovered on 03Jun2021. Events were reported as serious with medically significant. Therapeutic measures were taken as a result of all events reported as took Anadin (aspirin and paracetamol), drunk lots of water and rested to recover. The patient underwent lab tests and procedures which included COVID-19 virus test: No - Negative on an unspecified date. Patient has not had symptoms associated with COVID-19. Patient is not enrolled in clinical trial. Patient has not tested positive for COVID-19 since having the vaccine. No follow-up attempts are possible. Information about batch/lot number cannot be obtained.


VAERS ID: 1415773 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-02
   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: Fatigue, SARS-CoV-2 test, Urinary tract infection
SMQs:, 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 INC2021657644

Write-up: This is a spontaneous report from a contactable consumer. This is a report received from the United Kingdom''s Medicines and Healthcare products Regulatory Agency. A 32-year-old female patient received bnt162b2 (Batch/Lot Number: EW3143), via an unspecified route of administration on 01Jun2021 as first, single dose for covid-19 immunization. Medical history included suppressed lactation from an unknown date and unknown if ongoing. 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. The patient''s concomitant medications were not reported. The patient experienced UTI (urinary tract infection), tiredness on 02Jun2021. The events were serious per medically significant. The patient underwent lab tests and procedures which included COVID-19 virus test: no - negative covid-19 test on an unspecified date. The outcome of events for UTI was not resolved, for tiredness was resolving. 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: 1415781 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-02
   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 NOT KNOWN / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Vestibular disorders (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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021657911

Write-up: Muscle pain; 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-202106041908384530-YU5YS. Safety Report Unique Identifier GB-MHRA-ADR 25423234. A female patient of an unspecified age received her first dose of bnt162b2 (Pfizer-BioNTech Covid-19 vaccine), via an unspecified route of administration on 02Jun2021 (Batch/Lot Number: Not known) as a single dose for covid-19 immunisation. The patient''s medical history was 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. The patient''s concomitant medications were not reported. The patient experienced muscle pain and dizziness on 02Jun2021. The events were reported as medically significant. The patient was recovering from the event muscle pain and recovered from dizziness on 04Jun2021. 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 obtained.


VAERS ID: 1415793 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-02
   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 ET8885 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain upper, Chills, Diarrhoea, Headache, Pyrexia, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (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: CERELLE; IBUPROFEN; SUMATRIPTAN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic migraine; Clot blood (Previous suspected); Contraception; Headache; Lactation decreased; Pregnancy
Allergies:
Diagnostic Lab Data: Test Date: 20210602; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021657742

Write-up: chills; stomach ache; Stomach pain; Diarrhea; Fever chills; Headache; This is a spontaneous report from a contactable consumer received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202106041958129150-UXSSW. Safety Report Unique Identifier GB-MHRA-ADR 25423542. A 29-year-old female patient received the first dose of bnt162b2(PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 02Jun2021 (at the age of 29 years old) (Lot Number: ET8885) as single dose for COVID-19 immunization. Medical history included Chronic migraine for last 15 years, Lactation decreased, contraception, headache, Previous suspected blood clot during pregnancy in 2017. 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. Concomitant medications included desogestrel (CERELLE) taken for contraception, ibuprofen for Headache, sumatriptan for Migraine. The patient experienced chills on an unspecified date, stomach ache on an unspecified date, stomach pain on 03Jun2021, diarrhea on 03Jun2021, headache on 02Jun2021, fever chills on 03Jun2021. The case was serious (medical significant). Therapeutic measures were taken as a result of headache. It was reported that Stomach ache and chills, followed by diarrhoea and a painful headache. 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 on 02Jun2021. The outcome of the event stomach pain (occurred on 03Jun2021) was recovering, of diarrhea and fever chills was recovered on 03Jun2021, of headache was recovered with sequelae, of the other events was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1415809 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-30
Onset:2021-06-02
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Axillary pain, Loss of personal independence in daily activities, Pain in extremity, SARS-CoV-2 test, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Dementia (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: ASPIRIN [ACETYLSALICYLIC ACID]; BROMOCRIPTINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Headache; Lactation decreased; Prolactin
Allergies:
Diagnostic Lab Data: Test Date: 20210529; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021657613

Write-up: pain in arm; Swollen feeling; difficult to do much work; Armpit 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-202106042143108240-PJF3Z, Safety Report Unique Identifier GB-MHRA-ADR 25424320. 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 left arm on 30May2021 (Lot number not unknown) at single dose for covid-19 immunisation. Medical history included lactation decreased from an unknown date, headache from an unknown date, prolactin from an unknown date. 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 medications included aspirin [acetylsalicylic acid] taken for headache from 29May2021 to 29May2021; bromocriptine taken for prolactin from 14May2021. The patient experienced pain in arm on an unspecified date, armpit pain on 02Jun2021. The clinical course was reported as follows: the patient took vaccine on Sunday. After that the patient had pain in arm where she took the jab but that pain was what people commonly get after vaccine. The patient started jogging from Tuesday when her arm pain was improving and by Wednesday she think her arm pain was better. However since Wednesday the patient would say she started to feel bit heavy in her arm pit and slight pain. Since today her pain and swollen feeling has increased and she felt it extending to her back and collar bone. The patient was finding it difficult to do much work by her left arm (i.e. vaccine arm). Patient has not tested positive for COVID-19 since having the vaccine. The patient underwent lab test included COVID-19 virus test: negative(No - Negative COVID-19 test) on 29May2021. The events were serious as medically significant. The outcome of the event pain in arm was recovering, of the other events was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1415810 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-10
Onset:2021-06-02
   Days after vaccination:23
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: Asthenia, Dizziness, Dysmenorrhoea, Heavy menstrual bleeding, Mental fatigue, Nausea, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Anticholinergic syndrome (broad), Guillain-Barre 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: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Date: 20200805; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021657504

Write-up: dizziness; nausea; weakness/lack of energy; painful cramps; mental fogginess; Heavy periods/unusually large amount of menstral bleeding; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202106042155069500-FPF4N, Safety Report Unique Identifier GB-MHRA-ADR 25424839. A 29-year-old female patient received First dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), on 10May2021 as single dose for covid-19 immunisation. Medical history included suppressed lactation. 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. The patient''s concomitant medications were not reported. Unusually heavy period, especially on day 2. Symptoms included unusually painful cramps (which negatively affected sleep), lack of energy, mental grogginess, physical weakness, dizziness, nausea, unusually large amount of menstral bleeding. Patient has not tested positive for COVID-19 since having the vaccine. The patient experienced dizziness, nausea, weakness, all on an unspecified date with outcome of unknown, heavy periods on 02Jun2021 with outcome of recovering. The lab tests included No - Negative COVID-19 test on 05Aug2020. All the events were assessed serious as medically significant. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1415850 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-14
Onset:2021-06-02
   Days after vaccination:19
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, Headache, Lymphadenopathy, Pyrexia, SARS-CoV-2 test
SMQs:, 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: 20210604; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021657296

Write-up: Fatigue; Swollen glands; Fever; Headache; This is a spontaneous report from a contactable consumer received from the Regulatory Authority (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202106050841384570-MWJ0K, and Safety Report Unique Identifier is GB-MHRA-ADR 25425207. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 14May2021 (lot/batch number was not reported) as 1st dose, single for COVID-19 immunisation. Medical history was not reported. Patient is not enrolled in clinical trial. Concomitant medications were not reported. On 02Jun2021, the patient experienced fatigue, swollen glands, fever and headache. Patient was suspected COVID-19 from 02Jun2021 and ongoing. The patient underwent lab test which included COVID-19 virus test: No - Negative COVID-19 test on 04Jun2021. The events were assessed as serious (medically significant) by the health authority. Patient has not tested positive for COVID-19 since having the vaccine. The outcome of all the events was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1415853 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-02
   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, Confusional state, Cough, Dizziness, Dry mouth, Fatigue, Feeling abnormal, Headache, Pyrexia, SARS-CoV-2 test, Suspected COVID-19
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (narrow), Dementia (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Vestibular disorders (broad), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Dehydration (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: 20210604; Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC2021657444

Write-up: headache got worse; Cough; Fatigue; Headache; Joint pain/sore joints; Tiredness; Dizziness; Confusion; Spaced out; suspected covid-19; Fever; Dry mouth; This is a spontaneous report from a contactable consumer received from the Medicines and Healthcare products Regulatory Agency (UK-MHRA). The regulatory authority report number is GB-MHRA-WEBCOVID-202106050855409590-B8NZ8, Safety Report Unique Identifier GB-MHRA-ADR 25425241. A 30-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 02Jun2021 17:00 (Lot number was not reported) at age of 30 years old as single dose for covid-19 immunisation. Medical history and concomitant medications were unknown. The patient previously received influenza vaccine (INFLUENZA VIRUS) on 03Jan2021 for routine vaccination. The patient was not enrolled in clinical trial. The patient experienced cough on 04Jun2021, fatigue on 03Jun2021, headache on 03Jun2021, headache got worse on 04Jun2021, dizziness on 03Jun2021, confusion on 03Jun2021, fever on 02Jun2021 22:00, joint pain/sore joints on 03Jun2021, tiredness on 03Jun2021, dry mouth on 02Jun2021, spaced out on 03Jun2021. The patient had suspected covid-19 from 03Jun2021 and ongoing. The patient underwent lab tests and procedures which included COVID-19 virus test: negative on 04Jun2021. Vaccine given circa 5pm, the patient had dry mouth started very quickly, fever by 10pm, woke up next day with serious spaced out feeling, confusion, sore joints, splitting sore head, felt fine the following morning, later that evening joint pain, cough, headache got worse. Paracetamol used to help. Outcome of the events cough, fatigue, headache, joint pain/sore joints, tiredness, dry mouth, suspected covid-19 was not recovered, of the events fever, spaced out was recovering, of the events dizziness, confusion was recovered, of the event headache got worse was unknown. This report is serious with seriousness criteria-other medically important condition. No follow-up attempts are possible, information about Batch/Lot Number cannot be obtained.


VAERS ID: 1415862 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-02
   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 EY5456 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Dizziness, Paraesthesia, Photophobia, Speech disorder, Swollen tongue, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Angioedema (narrow), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Oropharyngeal allergic conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (narrow), Glaucoma (broad), Cardiomyopathy (broad), Corneal disorders (broad), Retinal disorders (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (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: CONDYLINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Wart
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021657188

Write-up: Generalised joint pain; faint; Dizziness; Light sensitivity to eye; Pins and needles; Swollen tongue; speech became a little more difficult; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202106051002061980-MI26Q, and Safety Report Unique Identifier is GB-MHRA-ADR 25425415. A 28-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 02Jun2021 (lot number: EY5456) as 1st dose, single for COVID-19 immunisation. Medical history included wart. Patient has not had symptoms associated with COVID-19 and has not had a COVID-19 test. Patient is not enrolled in clinical trial. Concomitant medication included podophyllotoxin (CONDYLINE) taken for wart. The patient experienced generalised joint pain on an unspecified date; and faint, dizziness, light sensitivity, pins and needles, swollen tongue and speech became a little more difficult, all on 02Jun2021. The events were assessed as serious (medically significant) by the health authority. Additional Information: Dizziness started initially, patient then looked up and was very sensitive to light and the dark areas of the room felt particularly dark. Felt like he was about to faint until he got assistance. Then pins and needles started in his hands and remained for 5 minutes. Simultaneously, his speech became a little more difficult as if his tongue was swollen. The nurses gave me a couple of biscuits and some water and the symptoms were resolved within half an hour. Patient has not tested positive for COVID-19 since having the vaccine. The outcome of all the events was recovered on 02Jun2021. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1415878 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-02
   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 EW3143 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Headache, Malaise, Migraine, Photophobia, SARS-CoV-2 test, Vision blurred
SMQs:, Anticholinergic syndrome (broad), Noninfectious meningitis (narrow), Glaucoma (broad), Lens disorders (broad), Corneal disorders (broad), Retinal disorders (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 Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021657330

Write-up: blurry vision; headaches; migraines; Feel sick; Photophobia; This is a spontaneous report from a contactable consumer (patient) received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202106051135242700-PM9JE. Safety Report Unique Identifier GB-MHRA-ADR 25425591. A 32-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 02Jun2021 (Lot Number: EW3143) (at the age of 32-years-old) 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, was not enrolled in clinical trial, and was not pregnant. On 02Jun2021, the patient experienced photophobia. On 03Jun2021, the patient experienced blurry vision, headaches, feel sick and migraines. The clinical course was also reported as follows: Evening of first jab, light seemed really bright and uncomfortable. Next day, working at screen had to come away due to blurry vision and headaches. Spent day in a room with black out blinds and lights off with sunglasses on. Light made her feel sick and migraines. The events were considered serious, medically significant. The patient underwent lab tests and procedures which included COVID-19 test: No - Negative COVID-19 test on unspecified date. Patient has not tested positive for COVID-19 since having the vaccine. The outcome of photophobia was recovered on 04Jun2021, blurry vison was resolving, while outcome of the events headaches, feel sick, and migraines was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1415892 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-02
   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: Haemorrhage, Heavy menstrual bleeding, Menstruation irregular, 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: Lactation decreased; Comments: Unsure if patient has 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: 20210601; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021657584

Write-up: bleeding; Period normally very regular but is now a week early.; Heavy periods; This is a spontaneous report from a contactable consumer received from the regulatory authority report number is GB-MHRA-WEBCOVID-202106051344118710-MGCN1. A 29-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 an unspecified age) as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included suppressed lactation. Unsure if patient had 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 heavy periods on 02Jun2021. Bleeding started day after vaccine. Period normally very regular but is now a week early. 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: Negative COVID-19 test on 01Jun2021. The outcome of bleeding was recovering, of Heavy periods was not recovered, of other event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1415940 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-02
   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: Abdominal pain upper, Decreased appetite, Diarrhoea
SMQs:, Acute pancreatitis (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (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: Clinical trial participant (COVID infection study); Inflammatory bowel disease (Taking medicines for inflammatory bowel disease (Crohn''s disease, ulcerative colitis)); Lactation decreased; Ulcerative colitis; Comments: Diagnosed with ulcerative colitis. Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test Patient is not pregnant,Patient is not currently breastfeeding
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021657807

Write-up: Stomach cramps; Diarrhea; Appetite absent; This is a spontaneous report from a contactable consumer, received from the regulatory authority (RA). Regulatory authority report number GB-MHRA-WEBCOVID-202106051939389080-RIKXF, Safety Report Unique Identifier GB-MHRA-ADR 25426383. A 33-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number was not reported), via an unspecified route of administration on 01Jun2021 (unknown age at time of vaccination) at single dose for COVID-19 immunization. Medical history included ulcerative colitis, lactation decreased, clinical trial participant (Study details: COVID infection study), inflammatory bowel disease (Taking medicines for inflammatory bowel disease (Crohn''s disease, ulcerative colitis)). The patient''s concomitant medications were not reported. The patient experienced stomach cramps, diarrhea, appetite absent on 02Jun2021. Events were assessed as serious with criteria of Other medically important condition. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient is not pregnant. Patient is not currently breastfeeding. The outcome of the events was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1416031 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-02
   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 EW3143 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Fatigue, Headache, Heart rate, Heart rate increased, Migraine, Palpitations
SMQs:, Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (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? No
Previous Vaccinations:
Other Medications: METHADONE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chest pain; Lactation decreased; Opioid abuse
Allergies:
Diagnostic Lab Data: Test Date: 20210604; Test Name: heart rate; Result Unstructured Data: Test Result:48-52 bpm; Comments: resting heart rate; Test Date: 20210604; Test Name: heart rate; Result Unstructured Data: Test Result:69-86 bpm; Comments: resting heart rate
CDC Split Type: GBPFIZER INC2021657700

Write-up: chronic fatigue; tight pain in my chest; Palpitations; raised heart rate; headache; Migraine; 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-202106052148230820-XOM2P, Safety Report Unique Identifier GB-MHRA-ADR 25426529. A 37-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 02Jun2021 (at the age of 37 years old) (Lot Number: EW3143) as single dose for COVID-19 immunisation. Medical history included lactation decreased, chest pain, Opioid abuse. 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. Concomitant medication included methadone taken for Opioid abuse from 10Mar2020. Put on a methadone reduction script early 2020 in order to comfortably come off a tramadol prescription. The patient previously took tramadol. The patient experienced headache (medically significant) on 02Jun2021, chronic fatigue (medically significant) on an unspecified date, palpitations (medically significant) on 04Jun2021, migraine (medically significant) on 02Jun2021, raised heart rate (medically significant) on 04Jun2021, tight pain in my chest (medically significant) on an unspecified date. Clinical course: Got a terrible headache within 5 minutes of receiving vaccine and still have it 4 days later, got marginally better after pain relief but never completely goes. 2 days after the vaccine she started suffering with raised heart rate - resting heart rate gone from 48-52 bpm to now 69-86 bpm. She was also suffering with palpitations and a tight pain in her chest. The 4th side effect was chronic fatigue - which bothered her far less than the headaches and palpitations. Patient has not tested positive for COVID-19 since having the vaccine. The outcome of the events palpitations, migraine was not recovered, of the events heart rate increased, chest pain was unknown, of the other events was recovering. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1416094 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chest pain, Chills, Cough, Fatigue, Migraine, Migraine with aura, Pleurisy, Pyrexia, Somnolence
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), 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: SERTRALINE
Current Illness:
Preexisting Conditions: Comments: No medical history was reported
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Migraine; Severe chills; Dry cough; Chest pain; Fatigue; Pleurisy; Fever chills; Migraine aura; Drowsiness; This regulatory authority case was reported by a consumer and describes the occurrence of MIGRAINE (Migraine), CHILLS (Severe chills), COUGH (Dry cough), CHEST PAIN (Chest pain), FATIGUE (Fatigue), PLEURISY (Pleurisy), PYREXIA (Fever chills), MIGRAINE WITH AURA (Migraine aura) and SOMNOLENCE (Drowsiness) in a patient of an unknown age and gender who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. No medical history was reported. Concomitant products included SERTRALINE for Anxiety depression. On 02-Jun-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 02-Jun-2021, the patient experienced SOMNOLENCE (Drowsiness) (seriousness criteria disability and medically significant). On 03-Jun-2021, the patient experienced MIGRAINE WITH AURA (Migraine aura) (seriousness criteria disability and medically significant). On 04-Jun-2021, the patient experienced PYREXIA (Fever chills) (seriousness criteria disability and medically significant). On 09-Jun-2021, the patient experienced PLEURISY (Pleurisy) (seriousness criteria disability and medically significant). On an unknown date, the patient experienced MIGRAINE (Migraine) (seriousness criteria disability and medically significant), CHILLS (Severe chills) (seriousness criteria disability and medically significant), COUGH (Dry cough) (seriousness criteria disability and medically significant), CHEST PAIN (Chest pain) (seriousness criteria disability and medically significant) and FATIGUE (Fatigue) (seriousness criteria disability and medically significant). On 04-Jun-2021, PYREXIA (Fever chills) and MIGRAINE WITH AURA (Migraine aura) had resolved. On 05-Jun-2021, SOMNOLENCE (Drowsiness) had resolved. At the time of the report, MIGRAINE (Migraine), CHILLS (Severe chills), COUGH (Dry cough), CHEST PAIN (Chest pain) and FATIGUE (Fatigue) was resolving and PLEURISY (Pleurisy) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant medications were provided by the reporter. No treatment medications were provided by the reporter. The patient was unsure if any symptoms associated with COVID-19 and not had a COVID-19 test, as the patient was not enrolled in clinical trial The patient had drowsiness after 5-6 hours, followed by 24 hours of fatigue, severe chills, migraine and light/temperature sensitivity at 46-48hours. Dry cough started 4 days after jag and chest pain when breathing begun 1 week after jag. Patient had not tested positive for COVID-19 since having the vaccine. Company comment: 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: 1416134 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-06-02
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Alopecia, Eczema, Haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (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:
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: GBPFIZER INC2021670696

Write-up: Bleeding; Hair loss on legs; bleeding from spot like marks on head; This is a spontaneous report from a contactable consumer (patient). A 29-years-old male patient received bnt162b2 ((PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunisation. There was no medical history. The patient''s concomitant medications were not reported. The patient had no other vaccine in four weeks, and no other medications in two weeks. The patient had no COVID prior vaccination and had not tested post vaccination. The patient had no known allergies. On 02Jun2021, the patient experienced hair loss on legs, bleeding from spot like marks on head. No treatment was administered for the event. The event ''hair loss on legs'' was resolving at the time of the report while the outcome of the rest of the events was unknown. No follow-up attempts are possible; information about batch/lot number cannot be obtained.


VAERS ID: 1416216 (history)  
Form: Version 2.0  
Age: 74.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-02
   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 FC1131 / UNK LA / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Headache, Hypertension, Somnolence
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypertension (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: METFORMIN; INSULIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Name: Blood pressure; Result Unstructured Data: Test Result:119-280; Comments: high
CDC Split Type: ITPFIZER INC2021696912

Write-up: high pressure till to 119-280; headache; somnolence; This is a spontaneous report from a contactable consumer or other non hcp. A 74-years-old non-pregnant female patient received bnt162b2 (COMIRNATY, Formulation: Solution for injection, Lot number: Fc1131 and Expiration date: unknown), via an unknown route of administration, administered in left arm on 01Jun2021 at 09:45 (at the age of 74-years-old) as unknown, single dose for covid-19 immunisation. Medical history included type 2 diabetes mellitus. Concomitant medications included metformin 1000 mg, insulin, Kalumet 50/850 mg, ginkgo biloba, Butcher''s broom, horse chestnut and omega 3. The patient previously took paracetamol, cortisone, antibiotics, antipyretics and analgesics in general, carbonated gauze and cinnamon. Prior vaccination, patient was not diagnosed with covid-19, also since the vaccination patient has not been tested for covid-19. It was reported that, patient received vaccine on 01Jun2021 (Tuesday as reported), the next day on 02Jun2021 he experienced so much somnolence. On 03Jun2021 (Thursday as reported), he reported growing headaches. On same day, he measured the blood pressure and it was high (usually has low / normal blood pressure like 67-110) until it hit 119-280. Therapeutic measures were taken and included ramipril 2.5 mg/12.5 mg. Outcome of events was recovering. No follow up attempt needed. No further information expected.


VAERS ID: 1416230 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-02
   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 EY5420 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Body temperature, Depressed level of consciousness, Fall, Heart rate, Oxygen saturation, Presyncope, Vital signs measurement
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), 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? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: TELMISARTAN; AMLODIPINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension (under treatment with Telmisartan (40mg) 1Tablet, AMLODIPINE (25mg) 1Tablet for oral administration.)
Allergies:
Diagnostic Lab Data: Test Date: 20210602; Test Name: Blood pressure; Result Unstructured Data: Test Result:148/70; Test Date: 20210602; Test Name: body temperature; Result Unstructured Data: Test Result:35.2 Centigrade; Comments: before vaccination; Test Date: 20210602; Test Name: Pulse rate; Result Unstructured Data: Test Result:74; Test Date: 20210602; Test Name: SPO2; Test Result: 98 %; Test Date: 20210602; Test Name: Vital signs; Result Unstructured Data: Test Result:normal
CDC Split Type: JPPFIZER INC2021658915

Write-up: Loss of posture; Consciousness clouding; Vasovagal reaction; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21111886. The patient was a 72-year-old female. Body temperature before vaccination was 35.2 degrees Centigrade. Other medical history included Hypertension. The Hypertension was under treatment with Telmisartan (40mg) 1Tablet, AMLODIPINE (25mg) 1Tablet for oral administration. The course of the event was as follows: On 02Jun2021 at 14:17 (the day of vaccination), the patient received the first dose (0.3ml) of BNT162B2 (COMIRNATY, Solution for injection, Lot number EY5420, Expiration date 31Aug2021), intramuscular as a single dose for COVID-19 immunization. The patient has no history of allergies. The patient was observed for 15 minutes and returned home. On 02Jun2021 around 15:00 (43 minutes after the vaccination), the patient experienced loss of posture 50 meters away from our hospital and was found by pedestrians and sent to our hospital. When the patient was sent to our hospital, the patient experienced Consciousness clouding, but blood pressure was 148/70, pulse rate was 74, SPO2 was 98% and vital signs were normal. Considering the possibility of Anaphylaxis and the patient was injected with EPIPEN 0.3mg via intramuscular injection in the left thigh. Then the patient was transferred to the PRIVACY hospital by ambulance and after the patient was observed, the patient was admitted to the hospital on 02Jun2021. On 03Jun2021, the patient was discharged from hospital. After physician''s diagnosis, it might be Vasovagal reaction. On 03Jun2021 (1 day after the vaccination), the outcome of the event was recovered. The reporting physician classified the event as serious (Hospitalization, admitted on 02Jun2021 and discharged on 03Jun2021) 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 Vasovagal reaction companied by vaccination.; Reporter''s Comments: It was thought to be Vasovagal reaction companied by vaccination.


VAERS ID: 1416238 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-31
Onset:2021-06-02
   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 FA4597 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Erythema multiforme, Pruritus, Rash
SMQs:, Severe cutaneous adverse reactions (narrow), Anaphylactic reaction (broad), Hypersensitivity (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? 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: 20210531; Test Name: body temperature; Result Unstructured Data: Test Result:36.0 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC2021659351

Write-up: Erythema exudativum; Exanthema generalised; itching of all body; This is a spontaneous report from a contactable physician received from the Regulatory Agency. Regulatory authority report number is v21111882. The patient was a 73-year-old female. Body temperature before vaccination was 36.0 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 31May2021 at 16:00 (the day of vaccination), the patient received the first dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number FA4597, Expiration date 31Aug2021) via an unspecified route of administration as a 1ST DOSE, SINGLE (received at the age of 73-years-old) for COVID-19 immunization. Medical history and concomitant medications were not reported. On 02Jun2021 at 06:00 (2 days after the vaccination), the patient experienced adverse events. On 04Jun2021 (2 days after the vaccination), the outcome of the events was not recovered. The course of the event was as follows: On 02Jun2021 morning, the patient woke up because of Exanthema generalized and itching of all body. On 03Jun2021, Anti-allergic agent was prescribed. (Erythema exudativum over the whole body was considered). On 04Jun2021, the patient went to PRIVACY clinic, Dermatology for a treatment and received the administration. 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 considered as the side effects of vaccine, and the patient was being treated in dermatology department.


VAERS ID: 1416252 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-24
Onset:2021-06-02
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 2Y2173 / 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? Yes
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 INC2021661320

Write-up: Cerebral infarction; This is a spontaneous report received from a contactable nurse via a Pfizer sales representative. The patient was an 84-year-old female. On 24May2021 (the day of vaccination), the patient received the first single dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number 2Y2173(as reported)) via an unspecified route of administration for COVID-19 immunization. The details of the reaction was reported as follow: On 26May2021, the patient was sitting in a kneeling position due to memorial service. On 02Jun2021, the patient hospitalized for cerebral infarction. The patient received the drip and finished it on 05Jun2021. And now there was no symptoms such as paralysis. This event was found after using the product. No follow up attempts are possible. No further information is expected.; Sender''s Comments: Based on the temporal association, a possible contributory role of BNT162B2 to the development 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: 1416306 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-23
Onset:2021-06-02
   Days after vaccination:10
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: 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: ROSUVASTATINE [ROSUVASTATIN]
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC2021664579

Write-up: brain infarction; This is a spontaneous report from a contactable consumer (patient). A 51-year-old male patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 23May2021 (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for COVID-19 immunisation. The patient''s medical history was not reported. Concomitant medications included rosuvastatine [rosuvastatin] (ROSUVASTATINE [ROSUVASTATIN]) taken for an unspecified indication, start and stop date were not reported and an unspecified medication for his blood pressure. The patient experienced brain infarction on 02Jun2021 with outcome of unknown. The patient went to the hospital urgently. It was not reported if he stayed at the hospital.


VAERS ID: 1416308 (history)  
Form: Version 2.0  
Age: 52.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-02
   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 FC2336 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Dyspnoea, Heart rate increased, Hypertension, Throat irritation
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Hypertension (narrow), Cardiomyopathy (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: Medical History/Concurrent Conditions: Allergy (hyperallergic)
Allergies:
Diagnostic Lab Data:
CDC Split Type: NOPFIZER INC2021668491

Write-up: A 52-years-old female patient received bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot Number: FC2336, Expiration date was not reported), dose 1 intramuscular, administered in Arm Left on 02Jun2021 11:30 (Age at vaccination 52 Years) as 1st dose, single for covid-19 immunization. Medical history included hypersensitivity (hyperallergic). The patient''s concomitant medications were not reported. On 02Jun2021 11:35 (5 minutes after) the patient experienced itchy throat, blood pressure high, dyspnea, high pulse rate. Due to lack of effect of treatment with first cortisone and then adrenaline and salbutamol she was hospitalized. she had clarified with the hospital in advance that the vaccine could be given. The outcome of event was not recovered. Reporter Comment: Clarified with the hospital in advance that the vaccine could be given. The vaccinator inject about 0.1ml first and waited for 10 seconds with no signs of allergic reaction. With the vaccinator for a few minutes before she went out to the observation room. The vaccinator contacted a physician and due to lack of response on treatment with cortisone, adrenaline and salbutamol the ambulance was contacted and the patient was hospitalized. Reporters qualification: Nurse. The Regional Pharmacovigilance Center assessed the causal relationship between bnt162b2 (COMIRNATY) and all the reported events as Possible.; Reporter''s Comments: Clarified with the hospital in advance that the vaccine could be given. The vaccinator inject about 0.1ml first and waited for 10 seconds with no signs of allergic reaction. With the vaccinator for a few minutes before she went out to the observation room. The vaccinator contacted a physician and due to lack of response on treatment with cortisone, adrenaline and salbutamol the ambulance was contaceted and the pateinet was hospitalized. Reportesrs qualification: Nurse.


VAERS ID: 1416310 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-05
Onset:2021-06-02
   Days after vaccination:28
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX6564 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Cor pulmonale, Investigation, Platelet count, Pulmonary embolism
SMQs:, Cardiac failure (narrow), Embolic and thrombotic events, venous (narrow), Pulmonary hypertension (narrow)

Life Threatening? Yes
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: Pulmonary embolism (Former pulmonary embolism, related to surgery. Time of event not stated in the report.)
Allergies:
Diagnostic Lab Data: Test Date: 20210602; Test Name: Investigation; Result Unstructured Data: Test Result:Bilateral central pulmonary embolism; Comments: Bilateral central pulmonary embolism with cor pulmonale.; Test Date: 202106; Test Name: Thrombocyte count; Result Unstructured Data: Test Result:Normal value; Comments: Normal value (test date not specified in the report).
CDC Split Type: NOPFIZER INC2021698906

Write-up: PULMONARY EMBOLISM; pulmonary embolism with cor pulmonale; This is a spontaneous report from a contactable physician downloaded from the regulatory authority number NO-NOMAADVRE-FHI-2021-Uj3xdz. A 75-year-old female patient received bnt162b2 (COMIRNATY, lot number: EX6564), dose 2 intramuscular, administered in Arm Left on 05May2021 as 2nd dose, single for covid-19 immunisation. Medical history included pulmonary embolism (former pulmonary embolism, related to surgery. Time of event not stated in the report). The patient''s concomitant medications were not reported. On 02Jun2021, the patient developed pulmonary embolism. The consumer states that the patient had no obvious provocative factors. No thrombocytopenia. Relevant laboratory findings and investigations included in the report: THROMBOCYTE COUNT in Jun2021, Normal value, INVESTIGATION, on 02Jun2021, Bilateral central pulmonary embolism with cor pulmonale. The outcome of the event was resolving. The case was considered to be Serious. This case was received from a Physician. The Regional Pharmacovigilance Center assessed the causal relationship between bnt162b2 (COMIRNATY) and all the reported events as Possible. No follow-up attempts possible. No further information expected.


VAERS ID: 1416658 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-02
   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: Dry skin, Dyspnoea, Fatigue, Lymph node pain, Malaise, Pain, Pain in extremity, SARS-CoV-2 test, Somnolence, Wheezing
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Asthma/bronchospasm (broad), Anticholinergic syndrome (broad), Dementia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (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: CODEINE
Current Illness: Asthma (Mild); Eczema
Preexisting Conditions: Medical History/Concurrent Conditions: C-section (Patient had a C-Section in March); Lactation decreased; Low back pain; Shortness of breath
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Groggy; Pain; Feeling unwell; Wheezy; Lymph node pain; Dry skin; Painful arm; Fatigue; Shortness of breath; This regulatory authority case was reported by a consumer and describes the occurrence of WHEEZING (Wheezy) and DYSPNOEA (Shortness of breath) in a 31-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 Shortness of breath, Lactation decreased, Low back pain and C-section (Patient had a C-Section in March). Concurrent medical conditions included Eczema and Asthma (Mild). Concomitant products included CODEINE for Low back pain. On 02-Jun-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Jun-2021, the patient experienced DYSPNOEA (Shortness of breath) (seriousness criterion medically significant), PAIN IN EXTREMITY (Painful arm) and FATIGUE (Fatigue). On 04-Jun-2021, the patient experienced DRY SKIN (Dry skin). On 09-Jun-2021, the patient experienced LYMPH NODE PAIN (Lymph node pain). On an unknown date, the patient experienced WHEEZING (Wheezy) (seriousness criterion medically significant), SOMNOLENCE (Groggy), PAIN (Pain) and MALAISE (Feeling unwell). On 03-Jun-2021, FATIGUE (Fatigue) had resolved. On 04-Jun-2021, PAIN IN EXTREMITY (Painful arm) had resolved. At the time of the report, WHEEZING (Wheezy), SOMNOLENCE (Groggy), PAIN (Pain) and MALAISE (Feeling unwell) had resolved and DYSPNOEA (Shortness of breath), DRY SKIN (Dry skin) and LYMPH NODE PAIN (Lymph node pain) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) was unknown. No treatment information was provided. Patient did not experience any side effects until about 6 hours after the vaccine. Later, patient felt very tired and her arm was sore. Not long after this, patient developed dry skin on her arm around the site of the vaccine, similar to eczema (which was completely new for her). She has also struggled with shortness of breath and felt very wheezy ever since the vaccination. She had mild asthma. However, did not struggle often with symptoms like that, which made her think if it was related to the vaccine. Lastly, she had lot of pain under her armpit, in the same vaccinated arm which led her to believe that it might be the lymph nodes which had swollen. She generally felt unwell and groggy since the vaccination. Patient had not tested positive for COVID-19 since vaccination. Patient continued conducting Lateral Flow tests, which had been negative. 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: 1417451 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-06-02
Submitted: 0000-00-00
Entered: 2021-06-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Facial paralysis, Facial spasm, Muscle spasms
SMQs:, Dystonia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Hearing impairment (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:
CDC Split Type: AUPFIZER INC2021704362

Write-up: facial paralysis; facial spasm; Muscle spasms; This is a spontaneous report from a contactable other health professional via the Agency Regulatory Authority. Regulatory authority report number is 564951. A 39-years-old female patient received BNT162b2 (COMIRNATY, solution for injection, Lot Number: unknown), via an unspecified route on unspecified date as unknown, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 02Jun2021, the patient experienced facial paralysis, facial spasm, muscle spasms. The outcome of the events was recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1417552 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-06-02
Submitted: 0000-00-00
Entered: 2021-06-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Back pain, Blood culture, Blood test, HIV infection, Hepatitis A antibody, Hepatitis B antibody, Hepatitis C antibody, Laboratory test abnormal, Leptospira test, Lymphadenopathy, Myalgia, Neck pain, Odynophagia, Positron emission tomogram, Pyrexia, Ultrasound scan
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Arthritis (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? Yes, 12 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Weight loss
Allergies:
Diagnostic Lab Data: Test Name: HIV infection; Result Unstructured Data: negative; Test Name: Hepatitis A antibody; Result Unstructured Data: negative; Test Name: Hepatitis B antibody; Result Unstructured Data: negative; Test Name: Hepatitis C antibody; Result Unstructured Data: negative; Test Name: Blood culture; Result Unstructured Data: Negative; Test Name: Laboratory test abnormal; Result Unstructured Data: elevated; Test Name: PET/CT scan; Result Unstructured Data: febrile syndrome of unknown origin; Test Name: Diagnostic ultrasound; Result Unstructured Data: Adenomegalias in the bilateral zone II and III; Test Name: Blood test; Result Unstructured Data: Cytomegalovirus-negative viral load; Test Name: Leptospira test; Result Unstructured Data: negative
CDC Split Type: COJNJFOC20210628568

Write-up: ODYNOPHAGIA; DIFFUSE CERVICAL MUSCLE PAIN; ADENOPATHIES; DORSAL PAIN; WEAKNESS; FEBRILE SYNDROME OF UNKNOWN ORIGIN; MUSCLE PAIN; This spontaneous report received from a physician concerned a 21 year old of unspecified sex. The patient''s height, and weight were not reported. The patient''s past medical history included intentional weight loss. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) frequency 1 total, dose was not reported, administered on 18-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 02-JUN-2021, the patient took admission per 12-day clinical course consisting of fever, diffuse cervical muscle pain, muscle pain, dorsal pain, weakness, odynophagia ,adenopathies and febrile syndrome of unknown origin. Patient was hospitalized for 12 days. On unspecified date laboratory data included: Blood test (NR: not provided) Cytomegalovirus-negative viral load, Diagnostic ultrasound (NR: not provided) Adenomegalias in the bilateral zone II and III, HIV infection (NR: not provided) negative, Hepatitis A antibody (NR: not provided) negative, Hepatitis B antibody (NR: not provided) negative, Hepatitis C antibody (NR: not provided) negative, Blood cultures (NR: not provided) negative, Inflammatory markers (NR: not provided) elevated, Leptospira test (NR: not provided) negative, and PET/CT scan (NR: not provided) febrile syndrome of unknown origin showing diffuse and homogeneous hypermetabolism in the spleen and bone marrow, as well as multiple nodes and some adenopathies described on both sides of the diaphragm showing different degrees of metabolism, suggestive as the first possibility of a reactive lymphoid process of probable inflammatory/infectious etiology. Laboratory test also included negative heavy drop. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the odynophagia, diffuse cervical muscle pain, adenopathies, dorsal pain, febrile syndrome of unknown origin, muscle pain and weakness was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender''s Comments: V0:20210628568-COVID-19 VACCINE AD26.COV2-Odynophagia,Diffuse cervical pain, Adenopathies, Dorsal pain. 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). V0:20210628568-COVID-19 VACCINE AD26.COV2- febrile Syndrome of unknown origin, weakness, muscle pain. This event(s) is labeled per RSI and is therefore considered potentially related.


VAERS ID: 1418952 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-02
   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 NOT KNOWN / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Headache, Rash, Urticaria
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: SERTRALINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Depression; Suspected COVID-19 (Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021671643

Write-up: Hives; Rash/ patient''s left arm came out in a rash which spread down to his hands; Headache; This is a spontaneous report received from a contactable consumer (patient) via Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202106070940245770-DJW0G, Safety Report Unique Identifier is GB-MHRA-ADR 25429057. A 32-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not known), on 02Jun2021 (at the age of 32-year-old) as dose 1, single for COVID-19 immunisation. The patient''s medical history included suspected COVID-19 from 25Mar2020 (unsure when symptoms stopped), and depression. He had not had a COVID-19 test. Patient was not enrolled in clinical trial. Concomitant medications included sertraline taken for depression from 01Apr2020. The patient experienced hives on 03Jun2021, rash and headache both on 02Jun2021. All events were reported serious with medically significant criterion. It was reported that immediately after the vaccine patient''s left arm came out in a rash, which spread down to his hands. This eased off the following day (03Jun2021), but that evening came back very badly and also hives, both of which lasted over the weekend. Both of these seemed to be easing at the time of this report. Patient had not tested positive for COVID-19 since having the vaccine. The outcome of the events was not resolved for headache and resolving for all other events. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1422880 (history)  
Form: Version 2.0  
Age: 52.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-06-02
Submitted: 0000-00-00
Entered: 2021-06-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Deep vein thrombosis
SMQs:, Embolic and thrombotic events, venous (narrow), Thrombophlebitis (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: NLJNJFOC20210642432

Write-up: DEEP VEIN THROMBOSIS IN LEG ON THE LEFT; This spontaneous report received from a physician via a Regulatory Authority [EMEA EVHUMAN NLP, NL-LRB-00571806] concerned a 52 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, route of admin not reported), 0.5 ml, 1 dosage forms, 1 in total (drug start period: 4 days) administered on 29-MAY-2021 for covid-19 immunisation. The batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported. On 02-JUN-2021, the patient had deep vein thrombosis in leg on the left. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from deep vein thrombosis in leg on the left. This report was serious (Other Medically Important Condition).; Sender''s Comments: 20210642432-COVID-19 VACCINE AD26.COV2.S-Deep vein thrombosis. 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: 1424995 (history)  
Form: Version 2.0  
Age: 23.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-06-02
Submitted: 0000-00-00
Entered: 2021-06-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Hyperpyrexia, Nausea, Paraesthesia, Presyncope, Vaccination site pain
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (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:
CDC Split Type: ITJNJFOC20210642780

Write-up: HYPERPYREXIA UP TO 39?C, PAIN AT SITE OF INOCULATION AND PARESTHESIAS AT LEFT ARTO SUPERIOREUPPER LIMB). IN THE MORNING OF 05/06/2021: PRESYNCOPAL EPISODE ASSOCIATED WITH NAUSEA.; HYPERPYREXIA UP TO 39?C, PAIN AT SITE OF INOCULATION AND PARESTHESIAS AT LEFT ARTO SUPERIOREUPPER LIMB). IN THE MORNING OF 05/06/2021: PRESYNCOPAL EPISODE ASSOCIATED WITH NAUSEA.; HYPERPYREXIA UP TO 39?C, PAIN AT SITE OF INOCULATION AND PARESTHESIAS AT LEFT ARTO SUPERIOREUPPER LIMB). IN THE MORNING OF 05/06/2021: PRESYNCOPAL EPISODE ASSOCIATED WITH NAUSEA.; HYPERPYREXIA UP TO 39?C, PAIN AT SITE OF INOCULATION AND PARESTHESIAS AT LEFT ARTO SUPERIOREUPPER LIMB). IN THE MORNING OF 05/06/2021: PRESYNCOPAL EPISODE ASSOCIATED WITH NAUSEA.; HYPERPYREXIA UP TO 39?C, PAIN AT SITE OF INOCULATION AND PARESTHESIAS AT LEFT ARTO SUPERIOREUPPER LIMB). IN THE MORNING OF 05/06/2021: PRESYNCOPAL EPISODE ASSOCIATED WITH NAUSEA.; This spontaneous report received from a physician via a Regulatory Authority [EMEA EVHUMAN NLP, IT-MINISAL02-742556] concerned a 23 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: XD985 expiry: unknown) frequency 1 total, 1 dosage forms, administered on 02-JUN-2021 for covid-19 immunisation. No concomitant medications were reported. On 02-JUN-2021, the patient experienced Hyperpyrexia up to 39?C, pain at site of inoculation and paresthesias at left arto superiore upper Limb). In the morning of 05/06/2021: presyncopal episode associated with nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from Hyperpyrexia up to 39?C, pain at site of inoculation and paresthesias at left upper Limb). In the morning of 05/06/2021: presyncopal episode associated with nausea on 05-JUN-2021. This report was serious (Other Medically Important Condition).; Sender''s Comments:20210642780-COVID-19 VACCINE AD26.COV2.S- Hyperpyrexia up to 39?C, presyncopal episode, paresthesias at left arto superiore upper Limb. 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). 20210642780-COVID-19 VACCINE AD26.COV2.S- pain at site of inoculation, Nausea. This event(s) is labeled and is therefore considered potentially related.


VAERS ID: 1428368 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-31
Onset:2021-06-02
   Days after vaccination:63
Submitted: 0000-00-00
Entered: 2021-06-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EE8492 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Maternal exposure during pregnancy
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (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: FOLIC ACID
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Folic acid supplementation; Miscarriage; Pregnancy
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021683492

Write-up: Patient was exposed to the medicine first-trimester (1-12 weeks); Early miscarriage; This is a spontaneous report from a contactable consumer (patient). This is a report received from the Regulatory Agency (RA). Regulatory authority report number [GB-MHRA-WEBCOVID-202106091052235290-HJ5UO], Safety Report Unique Identifier [GB-MHRA-ADR 25443293]. A 34-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 31Mar2021 (Lot number: EE8492) as dose 2, single for COVID-19 immunisation. Medical history included miscarriage, pregnancy and folic acid supplementation, all from an unknown date and unknown if ongoing. Concomitant medications included folic acid taken for vitamin supplementation, start and stop date were not reported. The patient experienced early miscarriage and patient was exposed to the medicine first-trimester (1-12 weeks) on an unspecified date; and early miscarriage on 02Jun2021. The events were assessed as serious (medically significant). The outcome of the event ''early miscarriage'' was recovering and event ''Patient was exposed to the medicine first-trimester (1-12 weeks)'' was unknown. The clinical course was reported as follows: Conceived around the 28Mar2021, 2nd COVID vaccine on 31Mar2021, pregnancy didn''t progress beyond yolk scan forming (around 5 weeks) and expectant miscarriage started on the 02Jun2021. Patient has not tested positive for COVID-19 since having the vaccine. Child was exposed to the medicine: first-trimester (1-12 weeks). Patient was exposed to the medicine first-trimester (1-12 weeks). Details of scans or investigations: Miscarriage. Additional information: Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient was not enrolled in clinical trial. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1435135 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW3143 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Maternal exposure during pregnancy, Pain in extremity, SARS-CoV-2 test
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Tendinopathies and ligament disorders (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: FOLIC ACID
Current Illness: Pregnancy (Estimated due date: 10Feb2022)
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 INC2021700511

Write-up: Maternal exposure during pregnancy; Painful arm; This is a solicited report from a contactable consumer. This is a report received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-YCVM-202106132220483030-OI3Z4, Safety Report Unique Identifier GB-MHRA-ADR 25467898. A 31-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 02Jun2021 at the age of 31-year-old (Lot Number: EW3143) as single dose for COVID-19 vaccination. Medical history included ongoing pregnancy (Estimated due date: 10Feb2022). Patient had not had symptoms associated with COVID-19. Patient was not enrolled in clinical trial. Patient was not currently breastfeeding. Patient last menstrual period date: 08May2021. Concomitant medication included folic acid taken for Folic acid supplementation, start and stop date were not reported. The patient experienced maternal exposure during pregnancy on 02Jun2021 with outcome of unknown, painful arm on 02Jun2021 with outcome of recovered on 04Jun2021. The mother reported she became pregnant while taking bnt162b2. The mother was 3 Weeks pregnant at the onset of the event. The mother was due to deliver on 12Feb2022. The patient underwent lab tests and procedures which included COVID-19 virus test: No - Negative COVID-19 test on an unspecified date. This is a serious medically significant case provided by Health Authority assessed by reporter. The reporter''s assessment of the causal relationship of the event with the suspect products was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Based on temporal association, the reported event painful arm is considered related to BNT162B2. 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: 1468712 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY5456 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Maternal exposure during pregnancy, Scan, Vaginal haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: FOLIC ACID
Current Illness: Pregnancy (Estimated due date: 25Jul2021)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: scan; Result Unstructured Data: Test Result:normal
CDC Split Type: GBPFIZER INC2021683563

Write-up: Vaginal bleeding; Maternal exposure during pregnancy; This is a solicited report. Monitor program from a contactable consumer. This is a report received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-YCVM-202106022038353110-RC3BD. Safety Report Unique Identifier GB-MHRA-ADR 25448295. A 34-year-old female pregnant patient received first dose of BNT162B2 (PFIZER- BIONTECH COVID-19 VACCINE) (Lot Number: EY5456) via an unspecified route of administration on 02Jun2021, at the age of 34-year-old, at a single dose for COVID-19 vaccination. Medical history included ongoing pregnancy. Estimated due date: 25Jul2021. Concomitant medication included folic acid taken for folic acid supplementation, start and stop date were not reported. The patient was admitted to hospital 48 hours after vaccine with pre-term vaginal/membrane bleeding and early waters breaking (pregnancy). Monitored in hospital for 3 days. No proven link between this and the vaccine, but no other cause identified. Patient has not tested positive for COVID-19 since having the vaccine. Patient is unsure if vaccination had an adverse effect on any aspect of the pregnancy. Patient was exposed to the vaccine third-trimester (29-40 weeks). The reported events were: maternal exposure during pregnancy on 02Jun2021 with outcome of unknown, vaginal bleeding on 04Jun2021 with outcome of recovered on 04Jun2021. The patient was treated with erythromycin for vaginal bleeding from 05Jun2021 to 13Jun2021. The case was reported as serious due to hospitalization required. The patient hospitalized from 2021. The mother reported she became pregnant while taking bnt162b2. The patient underwent lab tests and procedures which included scan: normal on unknown date. The reporter''s assessment of the causal relationship of the events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. No follow-up attempts are possible. No further information is expected. Follow-up (20Jun2021): New information received from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-YCVM-202106022038353110-RC3BD. Safety Report Unique Identifier GB-MHRA-ADR 25448295, included: clinical data (event "painful arm" was deleted, treatment information updated, outcome detail information updated). No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Due to the known drug safety profile, the company cannot completely exclude a drug-event causal association between the reported painful arm and BNT162B2 administration. Conversely, based on the information currently provided, the company deems there is not a reasonable possibility that the vaginal bleeding in the setting of maternal exposure during pregnancy is related to BNT162B2. The impacts 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: 1473655 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET8885 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Maternal exposure during pregnancy, SARS-CoV-2 test, Scan, Vaginal haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (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? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FOLIC ACID
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma; Ectopic pregnancy
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test; Test Name: Scan; Result Unstructured Data: Test Result:all in right place; Comments: at 5 weeks, 2 days after vaccine. Scan was done because of bleeding/spotting
CDC Split Type: GBPFIZER INC2021773580

Write-up: Maternal exposure during pregnancy/exposed to the vaccine first-trimester; Vaginal bleeding; This is a solicited report from the HA from a contactable consumer. This is a report received from the Regulatory Agency (RA). Regulatory authority report number GB-MHRA-YCVM-202106021355120810-GUECJ, Safety Report Unique Identifier GB-MHRA-ADR 25510731. A 38-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 02Jun2021 (Lot Number: Et8885, at age of 38 years old) as single dose for COVID-19 vaccination. Medical history included asthma and previous ectopic pregnancy. Estimated due date: 04Feb2022 (reported as 03Jan2022). Patient last menstrual period date: 30Apr2021. Patient had no symptoms associated with COVID-19. Patient was not enrolled in clinical trial. Patient was not currently breastfeeding. Concomitant medication included folic acid taken for vitamin supplementation. The patient experienced maternal exposure during pregnancy on an unspecified date, vaginal bleeding on 02Jun2021. Patient was exposed to the vaccine first-trimester (1-12 weeks). Events were reported as medical significant. Patient was unsure if vaccination had an adverse effect on any aspect of the pregnancy. The patient underwent lab tests and procedures which included COVID-19 virus test: no - negative on unknown date. Scan at 5 weeks, 2 days after vaccine, all in right place. Scan was done because of bleeding/spotting. Patient had not tested positive for COVID-19 since having the vaccine. The outcome of event vaginal bleeding was recovered on 14Jun2021, the outcome of maternal exposure during pregnancy was unknown. The reporter''s assessment of the causal relationship of the events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Based on the temporal association, a causal relationship between the events and BNT162B2 cannot be completely 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: 1484405 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Dizziness, Hypotension, Maternal exposure during pregnancy, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad), Dehydration (broad), Hypokalaemia (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: FOLIC ACID
Current Illness: Pregnancy
Preexisting Conditions: Medical History/Concurrent Conditions: Folic acid supplementation
Allergies:
Diagnostic Lab Data: Test Name: Blood pressure; Result Unstructured Data: Test Result:Unknown result; Test Date: 20210602; Test Name: Blood pressure; Result Unstructured Data: Test Result:low
CDC Split Type: GBPFIZER INC2021683480

Write-up: Maternal exposure during pregnancy/ Patient was exposed to the medicine Second-trimester (13-28 weeks)/16 weeks pregnant at time of vaccine; Fainted; Low blood pressure; Lightheaded; This is a spontaneous report from a contactable other healthcare professional received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202106091651121210-DQENF, Safety Report Unique Identifier GB-MHRA-ADR 25446001. A 34-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 02Jun2021 (Batch/Lot number was not reported) (at the age of 34-years-old) as DOSE 1, SINGLE for COVID-19 immunisation. Medical history included ongoing pregnancy and folic acid supplementation. The patient had no long term conditions and was 16 weeks pregnant at time of vaccine. Patient''s last menstrual period date was on 09Feb2021. Patient has not had symptoms associated with COVID-19, not had a COVID-19 test. Patient was not enrolled in clinical trial and not currently breastfeeding. Concomitant medication included folic acid taken for folic acid supplementation. On 02Jun2021, experienced lightheaded and fainted approximately one hour after vaccine. Patient also had low blood pressure on the same day. Patient also experienced maternal exposure during pregnancy. Patient was exposed to the medicine second-trimester (13-28 weeks). The events maternal exposure during pregnancy and low blood pressure were considered non-serious by reporter and regulatory authority; Pfizer assessed the events fainted and maternal exposure during pregnancy serious, medically significant and rest of events non-serious. The patient underwent lab tests and procedures which included monitoring of blood pressure: unknown result. Patient has not tested positive for COVID-19 since having the vaccine. The report was not related to possible blood clots or low platelet counts. The outcome of the event low blood pressure was recovered on 06Jun2021, while outcome of the rest 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: 1491784 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-26
Onset:2021-06-02
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET8885 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous
SMQs:, Termination of pregnancy and risk of abortion (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: Medical History/Concurrent Conditions: Clinical trial participant (Study details: Office for national statistics and ox unu)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021853622

Write-up: Miscarriage; This is a spontaneous report from a contactable consumer received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202107032055248410-QVPJW. Safety Report Unique Identifier is GB-MHRA-ADR 25591252. This is a maternal report. A pregnant female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: Et8885) via an unspecified route of administration on 26May2021 as dose 1, single for COVID-19 immunization. Medical history included clinical trial participant, study details: Office for national statistics and ox unu. Patient has not had symptoms associated with COVID-19 and she has not had a COVID-19 test. There were no concomitant medications, patient had no other meds taken at time. The patient experienced miscarriage on 02Jun2021. The event was reported as serious per hospitalization (2021) and other medically important condition. Patient has not tested positive for COVID-19 since having the vaccine. The pregnancy resulted in spontaneous abortion. The outcome of the event was not recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1364287 (history)  
Form: Version 2.0  
Age: 12.0  
Sex: Male  
Location: New Jersey  
Vaccinated:2021-05-28
Onset:2021-06-01
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-06-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Chest discomfort, Chest pain
SMQs:, Anaphylactic reaction (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (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: No
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data:
CDC Split Type:

Write-up: Chest pain, tightness


VAERS ID: 1364491 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-05-25
Onset:2021-06-01
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-06-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Injection site pain, Injection site rash, Injection site swelling, Pain
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (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: Na
Current Illness: Na
Preexisting Conditions: Na
Allergies: Cefzil
Diagnostic Lab Data:
CDC Split Type:

Write-up: I have a painful almost baseball size know that feels like there is a rash at injection site. Didn?t really notice it until this morning it is sore to the touch and movement is uncomfortable. Sister in law told me to report it.


VAERS ID: 1364499 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Male  
Location: Vermont  
Vaccinated:2021-05-26
Onset:2021-06-01
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-06-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0177 / 2 LA / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Abnormal faeces, Faeces discoloured, Fatigue, Haematochezia, Injected limb mobility decreased
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Gastrointestinal haemorrhage (narrow), Biliary system related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Noninfectious diarrhoea (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: 2 x 200mg Ibuprofen tablets 5/27 in the AM.
Current Illness: no
Preexisting Conditions: no
Allergies: no
Diagnostic Lab Data:
CDC Split Type:

Write-up: Same restricted mobility as first dose on left arm near vaccination location lasted 24-48h after second dose. Persistent fatigue (not after first dose), specially arms and legs. No other side effects until 06/1@8:00am blood in stool, foul-smelling. Usual shape/color.


VAERS ID: 1364521 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Virginia  
Vaccinated:2021-05-24
Onset:2021-06-01
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-06-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Rash erythematous
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (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: Don?t tolerate codene
Diagnostic Lab Data:
CDC Split Type:

Write-up: 6 days after vaccine, I noticed a red small circle at the injection site. I pressed on it slightly and noticed it hurt to the touch. The next day I woke up with a red rash at the injection site. It hurts to the touch still.


VAERS ID: 1364523 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Female  
Location: New York  
Vaccinated:2021-04-01
Onset:2021-06-01
   Days after vaccination:61
Submitted: 0000-00-00
Entered: 2021-06-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1805018 / 1 LA / SYR

Administered by: Other       Purchased by: ?
Symptoms: Heavy menstrual bleeding, Intermenstrual bleeding
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: armour thyroid 90 mg levothyroxin 25mg vitamin D 5m
Current Illness:
Preexisting Conditions: hypothyroid
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Breakthrough period bleeding. Longer period than ever


VAERS ID: 1364524 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Female  
Location: Utah  
Vaccinated:2021-05-30
Onset:2021-06-01
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-06-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 RA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Hypoacusis, Tinnitus
SMQs:, Hearing impairment (narrow)

Life Threatening? No
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: None
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data:
CDC Split Type:

Write-up: pulsatile tinnitus - constant - whooshing sound in ear correlating to the beat of my heart - hard time hearing


VAERS ID: 1364574 (history)  
Form: Version 2.0  
Age: 15.0  
Sex: Male  
Location: Florida  
Vaccinated:2021-06-01
Onset:2021-06-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 034C21A / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Interchange of vaccine products, Product administered to patient of inappropriate age
SMQs:, Medication errors (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: No concurrent Medications
Current Illness: None
Preexisting Conditions: No Chronic Health Conditions
Allergies: NKDA
Diagnostic Lab Data: none
CDC Split Type:

Write-up: Patient under 18 was accidently given the Moderna Dose instead of the Pfizer one indicated


VAERS ID: 1364601 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Massachusetts  
Vaccinated:2021-06-01
Onset:2021-06-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 036C21A / 2 RA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: No adverse event, Product administration error, Syringe issue, Underdose
SMQs:, Medication errors (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: N/A
Current Illness: NONE KNOWN
Preexisting Conditions: NONE KNOWN
Allergies: NONE
Diagnostic Lab Data: N/A
CDC Split Type:

Write-up: NEEDLE FAILURE, VACCINE WAS LEAKED OUT ; ONLY LESS THAN 20% VOLUME WAS ADMINISTERED ON LEFT ARM. OUTCOME : 1) IMMEDIATELY INFORMED PATIENT OF THE VACCINE ADMINISTRATION ERROR 2) ADMINISTER 0.5 ML MODERNA VACCINE IN THE OPPOSITE ARM ( RIGHT ARM) IMMEDIATELY . 3) PATIENT HAS NO SYMPTOMS .


VAERS ID: 1364611 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Female  
Location: New York  
Vaccinated:2021-06-01
Onset:2021-06-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0176 / 1 LA / IM

Administered by: Other       Purchased by: ?
Symptoms: Chest discomfort, Cough
SMQs:, Anaphylactic reaction (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: Influenza Vaccine
Other Medications: Losartan 50 mg, Norco, Flexeril, Phenergan, Hydroxyzine, Ventolin/Duoneb, Singular, Motrin, Hydrochlorothiazide, Benadryl, Lasix, Protonix, Famotidine, Symbicort, Levothyroxine, Spironolactone, Liothyronine, Senna-Docusate, Incruse ellipta
Current Illness:
Preexisting Conditions: Undifferentiated autoimmune disorder, lumbar pain, asthma, COPD, hypertension, hypothyroidism, PCOS, Reactive airway, Hashimoto''s disease
Allergies: Purrell, isopropyl alcohol, latex, sulfa, penicilline, EES, Zithromax, Keflex Biaxin, Clindamycin, tetracycline, Cymbalta, oxycodone, diltiazem, Amlodipine, Neurontin, Bactrim, Lyrica, Elavil, Celebrex silvadine ,Levaquin, lidocaine, Mobic mepivacaine, Doxycycline, aztreonam, chloride/bleach cleaning products chlorohexydine, tegretol, Effexor
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Patient in observation approximately 20 minutes after receiving the 1st dose of Pfizer presents with c/o chest tightness and dry cough. Patient has a history of anaphylaxis to multiple causes and was advised to stay in observation for 45 minutes. Patient was given oral fluids and evaluated by EMS. Patient requested to be transported to Hospital. Patient was alert and oriented x 4, denies difficulty breathing, shortness of breath, wheezing. Clear Lung sounds. Patient was started on Duo nebulizer at 09:05AM and transported to RGH 09:08AM. Initial Vitals (08:53AM): 130/88, HR 118, O2 Sat 93%, RR 20; Discharge Vitals (09:08AM): 127/83 HR 111 O2 Sat 100% RR 20.


VAERS ID: 1364636 (history)  
Form: Version 2.0  
Age: 23.0  
Sex: Male  
Location: Connecticut  
Vaccinated:2021-06-01
Onset:2021-06-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 009D21A / 1 RA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Chills, Headache, Hyperhidrosis
SMQs:, Neuroleptic malignant syndrome (broad), Hypoglycaemia (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: unknown
Current Illness: none
Preexisting Conditions: none
Allergies: none listed
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pt. received shot at 7:42 am. At 7:49 am pt. reported that he had a headache, sweats and chills. Monitored pt. He reported no difficulty breathing, no itching. BP at 8:02 am was 115/89 pulse 108 and pt. reported that chills and sweats were gone. At 8:12 am pt said he felt fine except a mild headache on the left side of his head. Pt. left pharmacy at that time. Advised pt. not to get 2nd dose of Moderna vaccine and to consult physician if any other symptoms develop throughout the day.


VAERS ID: 1364652 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Male  
Location: Unknown  
Vaccinated:2021-06-01
Onset:2021-06-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0177 / 2 RA / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Hyperhidrosis, Nausea, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Member in observation approx 10 mins after receiving vaccine became diaphoretic with complaints of nausea,. Member then began to vomit x 2.


VAERS ID: 1364654 (history)  
Form: Version 2.0  
Age: 61.0  
Sex: Female  
Location: Connecticut  
Vaccinated:2021-06-01
Onset:2021-06-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH WE0191 / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Pallor, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (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: No information
Current Illness: Unknown
Preexisting Conditions: No
Allergies: NKDA
Diagnostic Lab Data: N/A
CDC Split Type:

Write-up: Syncope. Her face was pale. Within 10 mins she was normal after we apply cold compress.


VAERS ID: 1364672 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Female  
Location: New Hampshire  
Vaccinated:2021-06-01
Onset:2021-06-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 207A21A / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Dizziness postural, Loss of consciousness
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (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? 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:

Write-up: After receiving a Jansen vaccine, pt got up to leave and started to complain that she was dizzy. Then, she slowly lost consciousness in this RN?s arms. Pt was lowered to the floor with her feet elevated in a chair. Pt regained her consciousness quickly and sat up for a while to make sure that pt was not dizzy any longer. After 15 minutes, pt went home with her mother.


VAERS ID: 1364675 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-06-01
Onset:2021-06-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0168 / 2 RA / IM

Administered by: Other       Purchased by: ?
Symptoms: Hypertension, Oedema peripheral, Palpitations, Refusal of treatment by patient, Tachycardia
SMQs:, Cardiac failure (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypertension (narrow), Cardiomyopathy (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? No
Previous Vaccinations:
Other Medications: Albuterol Montelukast
Current Illness: Denies
Preexisting Conditions: Asthma
Allergies: Denies
Diagnostic Lab Data:
CDC Split Type:

Write-up: 57 y/o female with past medical history of Asthma who presents with palpitations post vaccination administration. Patient states that this is her second dose in the two-dose series. Patient denies previous reaction with first dose. Patient states that received todays vaccination to the R arm. Patient states that she was nervous prior to receiving todays injection and that she suffers from anxiety (undiagnosed). Patient also states that she takes Albuterol daily and Montelukast. This NP explained to patient that Albuterol is a rescue medication and not a controller, that she is taking the medication incorrectly. I advised the patient to follow up with her primary physician to discuss a controller such as Pulmicort instead of using a rescue drug as maintenance. NP, CNO and Paramedics at patient side. Patient with noted peripheral edema. Patient initial vitals showed tachycardia and hypertension. Patient initial vitals (153/88 BP, 127 HR, 98% RA, Resp 16 and EKG Sinus Tachy). Patient states that her palpitations come and go. Patient denies sore throat, difficulty swallowing, chest pain or difficulty breathing. Patient monitored for 30 mins with no improvement of symptoms (Patient remained Hypertensive (171/88, 172/87, 174/94) and Tachycardia (105-127) and it was determined to call Fire Rescue. Fire Rescue assessed patient and advised to seek further medical attention but patient refuses. Patient signed AMA with rescue and patient was provided with the AshBritt Logistics and IEM Health AMA form, patient signed and ambulated off site without difficulty.


VAERS ID: 1364710 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Male  
Location: North Carolina  
Vaccinated:2021-06-01
Onset:2021-06-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0168 / 2 LA / IM

Administered by: Military       Purchased by: ?
Symptoms: Chest pain, Fatigue, Pharyngeal erythema, Throat irritation
SMQs:, Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (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: None
Current Illness: Post nasal drip and seasonal allergies
Preexisting Conditions: None
Allergies: NKDA
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pt states that prior to receiving vaccine he was having PND and rhinorrhea in the morning which had resolved before he arrived to the vax site. After receiving shot at 1023 pt states he started feeling fatigued, he had intermittent CP located at center of chest, non-radiating that lasted about 10 minutes, he also had a scratchy throat. Pt was given a benadryl PO at 1045. On PE, pt mild pharyngeal erythema, CTAB, RRR, CP had resolved and was non-reproducible, VSS, spO2 98, HR 81. Pt was advised to go to ED or urgent care for further evaluation, by 1100 pt stated he felt fatigued, but had no other symptoms. Pt was walked outside the vaccine facility where he had said his wife would we waiting, wife was not found. Pt was advised to drive himself to the ED/UC and f/u with his PCM the tomorrow morning 02JUN20201, pt verbalized understanding.


VAERS ID: 1364765 (history)  
Form: Version 2.0  
Age: 59.0  
Sex: Female  
Location: Massachusetts  
Vaccinated:2021-06-01
Onset:2021-06-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Chest discomfort, Cough, Dyspnoea, Feeling hot, Flushing, Hypersensitivity, Injection site pain, Nausea, Retching, Sputum increased
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (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: Annual flu vaccines. I have been advised not to obtain annual flu vaccines. Physician advised to get COVID-19 infection if I co
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Allergies: several allergies to antibiotics (penicillin), codeine derivatives, citrus products, and prior flu vaccines (protein-based vaccines)
Diagnostic Lab Data: CVS provided diphenhydramine (Benadryl, 25 mg tablets). Recovery from adverse event ongoing; now 90 minutes after vaccine injection
CDC Split Type:

Write-up: 15 minutes after injection started to feel facial flush, heat, nausea, followed in next 10 minutes by difficulty breathing, heavy chest, excessive mucus production, cough, gag on mucus. I have had multiple allergic responses. Controlled full allergic response with 2 diphenhydramine (25 mg each). Met with my personal care physician before COVID-19 vaccination to evaluate risks of vaccination. Doctor advised to proceed to obtain vaccination. Scheduled vaccination on date my husband was available in case of adverse response. 2 hours after injection arm started to hurt similar to what family members have reported as common responses to vaccine.


VAERS ID: 1364803 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Male  
Location: New York  
Vaccinated:2021-05-29
Onset:2021-06-01
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-06-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Electrocardiogram ST segment elevation, Myocarditis, Troponin T increased, Troponin increased
SMQs:, Myocardial infarction (narrow), Cardiomyopathy (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? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: None
Current Illness: No
Preexisting Conditions: No
Allergies: Peanuts, Pollen, Soy
Diagnostic Lab Data: hsTNT 203 then 300. EKG with diffuse ST elevation
CDC Split Type:

Write-up: Myocarditis


VAERS ID: 1364844 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Male  
Location: Virginia  
Vaccinated:2021-06-01
Onset:2021-06-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1821288 / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Blood glucose, Electrocardiogram, Hyperhidrosis, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (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: No record
Current Illness: Hypertension
Preexisting Conditions: None recorded
Allergies: None recorded
Diagnostic Lab Data: EKG, blood glucose, BP
CDC Split Type:

Write-up: Fainted, excessive sweating


VAERS ID: 1364847 (history)  
Form: Version 2.0  
Age: 20.0  
Sex: Female  
Location: Nebraska  
Vaccinated:2021-06-01
Onset:2021-06-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 006C21A / 1 RA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Dizziness, Syncope, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Fluoxetine 10mg Omeprazole 20mg
Current Illness: None
Preexisting Conditions: acid reflux. depression
Allergies: NKA
Diagnostic Lab Data: none at this facility
CDC Split Type:

Write-up: fainted. light headedness. vomiting. dizziness


VAERS ID: 1364848 (history)  
Form: Version 2.0  
Age: 23.0  
Sex: Female  
Location: Illinois  
Vaccinated:2021-06-01
Onset:2021-06-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 022C21A / 1 LA / IM

Administered by: Other       Purchased by: ?
Symptoms: Pharyngeal swelling, Rash, Throat irritation
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (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: None
Current Illness: None
Preexisting Conditions: None
Allergies: PCN Sulfa
Diagnostic Lab Data: Epi 0.3mg given and 25mg Benadryl IM
CDC Split Type:

Write-up: Itchy throat that advanced to swelling, rash both upper arms


VAERS ID: 1364849 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Female  
Location: North Carolina  
Vaccinated:2021-06-01
Onset:2021-06-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1808986 / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Dizziness, Nausea, Pain, Pain in extremity
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), 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: none noted
Current Illness: none noted
Preexisting Conditions: none noted
Allergies: none noted
Diagnostic Lab Data: BP /pulse- see results above
CDC Split Type:

Write-up: Pt given Vax at 11:11am, about 11:23am pt started feeling dizzy and nauseous. Pt laid on the floor and put feet on the chair. Ice pack provided to forehead at 11:28am, BP 11:31am 97/61 P53. Pt is talking, awake. said she moved her arm and was an influx of pain and that''s what made her dizzy. 11:40am- BP 107/67 P55. pt more awake and feeling better, 11:43am BP 102/74 P68. Pt sat up on her own, ate a few pieces of chocolate. feeling much better 11:52am BP 109/73 P 66 pt was able to stand up and feeling ok


VAERS ID: 1364859 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Male  
Location: Tennessee  
Vaccinated:2021-06-01
Onset:2021-06-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0187 / 2 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Unevaluable event
SMQs:

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:

Write-up: None 2 hours post vaccine


VAERS ID: 1364862 (history)  
Form: Version 2.0  
Age: 22.0  
Sex: Female  
Location: D.C.  
Vaccinated:2021-06-01
Onset:2021-06-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP6955 / 2 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Dizziness, Headache
SMQs:, Anticholinergic syndrome (broad), 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: Pfizer dose 1, tachycardia and high blood pressure with mild dizziness and headache
Other Medications: medroxyprogesterone, darbepotein alfa, PRN benadryl, PRN epi, PRN hydrocoritsone
Current Illness: none
Preexisting Conditions: complex medical history including POTS, "gut failure" followed by GI transplant team on TPN, mast cell activation syndrome with multiple allergies, prolonged QTc
Allergies: latex, peanuts, tree nuts, ativan, zosyn, betadine, clonazepam, ketamine, klonopin, ondansetron, tegaderm, cortisporin, vancomycin
Diagnostic Lab Data: none- just did three sets of vitals, all showing only mild tachycardia 100-110 (including her baseline set of vitals prior to vaccine)
CDC Split Type:

Write-up: developed headache and slight dizziness within minutes of vaccine administration.


VAERS ID: 1364873 (history)  
Form: Version 2.0  
Age: 20.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2021-06-01
Onset:2021-06-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 207A21A / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Cyanosis, Dizziness, Lethargy, Loss of consciousness, Pallor, Unresponsive to stimuli, Vision blurred, Visual impairment
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Retinal disorders (broad), Vestibular disorders (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? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data:
CDC Split Type:

Write-up: approximately two minutes after administration of vaccination patient had sat down in waiting area and became lethargic/dizzy/blurred vision. She had passed out with face pale and lips turning blue, minimally responsive. Called 911 and while awaiting for ambulance patient had recovered from all symptoms with the exception of "spotted visions." Observed patient for over an hour while a family member came and upon the time of departure there was resolution of all adverse events.


VAERS ID: 1364880 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Female  
Location: Kentucky  
Vaccinated:2021-06-01
Onset:2021-06-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 020B21A / 2 LA / IM

Administered by: Other       Purchased by: ?
Symptoms: Inappropriate schedule of product administration
SMQs:, Medication errors (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: none
CDC Split Type:

Write-up: Second dose was unknowingly given 2 weeks apart, not 4. Patient has tolerated well, waited 15 minutes in clinic with no issues


VAERS ID: 1364883 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Virginia  
Vaccinated:2021-06-01
Onset:2021-06-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0191 / UNK RA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Dizziness
SMQs:, Anticholinergic syndrome (broad), 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? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: patient felt dizzy after getting the pfizer covid shot , she mentioned she didn''t eat before she comes in, and kept watching her , making sure she is hydrating , patient said she feels much better, and good to go


VAERS ID: 1364890 (history)  
Form: Version 2.0  
Age: 23.0  
Sex: Male  
Location: Unknown  
Vaccinated:2021-06-01
Onset:2021-06-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Dizziness, Hyperhidrosis, Tunnel vision
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Optic nerve disorders (broad), Retinal disorders (narrow), Vestibular disorders (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:

Write-up: felt lightheaded, tunneling of vision, sweating, no LOC--started to feel better after 5-10 minutes vitals stable juice given


VAERS ID: 1364894 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Male  
Location: Michigan  
Vaccinated:2021-06-01
Onset:2021-06-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 207A21A / 1 RA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Blindness transient, Malaise, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Embolic and thrombotic events, arterial (narrow), Guillain-Barre syndrome (broad), Glaucoma (broad), Optic nerve disorders (broad), Retinal 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: unknown
Current Illness: unknown
Preexisting Conditions: unknown
Allergies: nkda
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient was told to have a seat in the waiting room for 15 minutes after vaccination. Against medical advice, he left immediately. Employee called the pharmacy and informed us patient was in the bathroom feeling like he was going to throw up, his vision was going black and he was tingling. Our pharmacist brought an epi-pen to the bathroom immediately, however, patient had left the building before pharmacist could evaluate him.


VAERS ID: 1364900 (history)  
Form: Version 2.0  
Age: 23.0  
Sex: Female  
Location: New York  
Vaccinated:2021-06-01
Onset:2021-06-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0186 / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Dizziness, Loss of consciousness
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Vestibular disorders (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? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No
Current Illness: No
Preexisting Conditions: Mitral valve prolapse
Allergies: No
Diagnostic Lab Data: N/A
CDC Split Type:

Write-up: Patient seemed fine after dose then complained of feeling dizzy. She passed out after sitting down.


VAERS ID: 1364901 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Male  
Location: Idaho  
Vaccinated:2021-06-01
Onset:2021-06-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER8736 / 1 LA / IM

Administered by: Public       Purchased by: ?
Symptoms: Dizziness, Hyperhidrosis, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (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: none known
Allergies: None known
Diagnostic Lab Data: vital signs
CDC Split Type:

Write-up: Diaphoresis with light-headness and fainting


VAERS ID: 1364905 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Male  
Location: Florida  
Vaccinated:2021-05-07
Onset:2021-06-01
   Days after vaccination:25
Submitted: 0000-00-00
Entered: 2021-06-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 027C21A / 1 LA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Arthralgia, Asthenia, Blood test, Limb discomfort, Muscle disorder, Pain in extremity, X-ray
SMQs:, Rhabdomyolysis/myopathy (broad), Guillain-Barre syndrome (broad), Arthritis (broad), Tendinopathies and ligament disorders (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: none
Current Illness: none
Preexisting Conditions: none
Allergies: none
Diagnostic Lab Data: Visited clinic,Wednesday 5/19/21 after no improvement. She issued Prednisone and Methocarbomol, and referred me to a sports medicine specialist that I visited on 5/24, Dr did a physical exam, xrays and blood work. Following up with him on 6/7/21. No for certain diagnosis, although he did mention the symptoms were similar to Parsonage-Turner syndrome.
CDC Split Type:

Write-up: Injection on Friday, by Sunday afternoon had severe pain in upper arm/shoulder/neck...debilitating pain. Loss of strength in left arm over the course of the following week, accompanied by extreme discomfort and muscle issues.


VAERS ID: 1364911 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Male  
Location: Texas  
Vaccinated:2021-06-01
Onset:2021-06-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 050C21A / 2 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Immunisation, Syringe issue, Underdose
SMQs:, 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: N/A
Current Illness: N/A
Preexisting Conditions: N/A
Allergies: N/A
Diagnostic Lab Data: N/A
CDC Split Type:

Write-up: THE SYRINGE DID NOT FUNCTION PROPERLY. DOSE RAN DOWN PATIENT''S ARM. RPH GAVE ANOTHER DOSE.


VAERS ID: 1364912 (history)  
Form: Version 2.0  
Age: 83.0  
Sex: Male  
Location: Massachusetts  
Vaccinated:2021-06-01
Onset:2021-06-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 206A21A / 1 LA / IM

Administered by: Senior Living       Purchased by: ?
Symptoms: Extra dose administered, Inappropriate schedule of product administration
SMQs:, Medication errors (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: lovenox, insulins
Current Illness: wound vac, and wounds
Preexisting Conditions: diabetic
Allergies: lisinopril and tricor
Diagnostic Lab Data: none- will continue to monitor resident for adverse effects.
CDC Split Type:

Write-up: resident received a 2nd dose of covid vaccine today 06/01/2021. resident consented to the medication. No notation in his chart of a previous vaccine. MD and family notified. Resident was was informed of the medication he was about to receive and did not make mention to the nurse that he had it previously. No adverse effects noted at this time. first dose was 4-2-2021


VAERS ID: 1364916 (history)  
Form: Version 2.0  
Age: 13.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-06-01
Onset:2021-06-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0191 / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Dizziness, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (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: penicillin, latex, kiwi, eggplant
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient had likely syncope. Fainted/felt dizzy after immunization. Patient waited at the pharmacy for 30min until she felt better, then went home.


VAERS ID: 1364921 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Female  
Location: Maryland  
Vaccinated:2021-06-01
Onset:2021-06-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 203A21A / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Asthenia, Eye movement disorder, Fall
SMQs:, Guillain-Barre syndrome (broad), Accidents and injuries (narrow), Ocular motility disorders (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: she stated that this happens all the time, although it was not indicated on her consent and release form
Other Medications: unknown
Current Illness: unknown
Preexisting Conditions: unknown
Allergies: unknown
Diagnostic Lab Data: n/a
CDC Split Type:

Write-up: Patient received the vaccine and approximately 5 mins later she fell to the ground, felt weak and eyes rolled back for just a second but did not completely lose consciousness. She was given a chair and she sat for approx 5 mins and when she went to leave the store, she fell to the ground again. Please note, she did not want to wait in the waiting room after the vaccine for the recommended amount of time that the pharmacist indicated.


VAERS ID: 1364940 (history)  
Form: Version 2.0  
Age: 65.0  
Sex: Female  
Location: California  
Vaccinated:2021-06-01
Onset:2021-06-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 002C21A / 2 RA / IM

Administered by: Private       Purchased by: ?
Symptoms: Dizziness, Hypertension
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypertension (narrow), Vestibular disorders (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: 1st dose of Moderna
Other Medications: Gabapentin, Albuterol, flonase, simvastatin, acyclovir, Benadryl, Calcium-VitD, Tylenol
Current Illness: none
Preexisting Conditions: HLD, CKD, MVP w/ pacemaker, osteopenia
Allergies: Alprazolam, Darvocet-N50, Flexeril, Fluoxetine, Naprosyn, nitroglycerin, Oxycontin, Percocet 5/325, Voxx, Zoloft
Diagnostic Lab Data: Pending evaluation in urgent care
CDC Split Type:

Write-up: Dizziness, lightheadedness, hypertension to 180/90


VAERS ID: 1364941 (history)  
Form: Version 2.0  
Age: 58.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-06-01
Onset:2021-06-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0168 / 1 LA / IM

Administered by: Other       Purchased by: ?
Symptoms: Electrocardiogram normal, Hypoaesthesia
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: Losartan Hydrochlorothiazide
Current Illness: Denies
Preexisting Conditions: Hypertension
Allergies: Denies
Diagnostic Lab Data:
CDC Split Type:

Write-up: 58 y/o female with past medical history of Hypertension who presents with left arm numbness post vaccination. Patient states that this is her first vaccination in the two-dose series. Patient denies previous reactions to vaccinations in the past. Patient states that she received the vaccination to the Left arm. Patient states that her left arm feels numbness or like it has fallen asleep. NP and Paramedics at patient side. Patient with equal pulses to bilateral upper extremities, cap refill less than 3 seconds, patient with FROM of the left upper extremity. Patient denies sore throat, difficulty swallowing, difficulty breathing and/or chest pain. Instructed patient to move/exercise the left upper extremity. Patient with Hypertension on initial vitals, 173/104 BP, 98% RA, 78 HR, 12 Resp, EKG NSR. Patient states that she took both of her blood pressure medications this am (Losartan and Hydrochlorothiazide). Within 30 mins patient with resolution of left arm numbness but hypertension remained. BP taken siting, lying, standing with no improvement. Patient BP increased to 182/107 and Rescue notified. Fire rescue was delayed in arriving. Patient was monitored by NP and Paramedics for over an hour. Once rescue arrived patient BP normalized to 150/99. Patient refused transport to ER. Patient signed AMA with rescue and patient was provided with the AMA form, patient signed and ambulated off site without difficulty.


VAERS ID: 1364947 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Female  
Location: Tennessee  
Vaccinated:2021-05-28
Onset:2021-06-01
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-06-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / IM

Administered by: Public       Purchased by: ?
Symptoms: Dizziness, Dyspnoea, Throat tightness
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Vestibular disorders (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? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: none
Preexisting Conditions: none
Allergies: multiple past medication allergies
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient complaint of shortness of breath and dizziness after receiving Covid 19 2nd dose. Felt as if her throat was constricting. Vital signs assessed and WNL. Patient stated symptoms were subsiding a few minutes after noticing and decreasing in severity. Patient was monitored for 45 minutes and displayed no signs of distress with vital signs remaining normal.


VAERS ID: 1364959 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Female  
Location: California  
Vaccinated:2021-06-01
Onset:2021-06-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 039B21A / 1 LA / IM
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0183 / 2 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Interchange of vaccine products
SMQs:, Medication errors (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: N/A
Current Illness: No
Preexisting Conditions: None
Allergies: No
Diagnostic Lab Data: No
CDC Split Type:

Write-up: patient first dose of Covid 19 vaccine was Modena, but for second dose Pfizer vaccine was given to patient mistakenly.


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