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

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



Case Details (Reverse Sorted by Onset Date)

This is page 251 out of 5,069

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VAERS ID: 1411917 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-03
Onset:2021-06-03
   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: Anaphylactic reaction, Body temperature, Choking sensation, Dysphagia, Oxygen saturation, Vital signs measurement
SMQs:, Anaphylactic reaction (narrow), Angioedema (broad), Anticholinergic syndrome (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (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? No
Previous Vaccinations:
Other Medications:
Current Illness: Rhinitis allergic
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210603; Test Name: body temperature; Result Unstructured Data: Test Result:36.4 Centigrade; Comments: before vaccination; Test Date: 20210603; Test Name: oxygen saturation; Test Result: 99 %; Test Date: 20210603; Test Name: vital; Result Unstructured Data: Test Result:Normal
CDC Split Type: JPPFIZER INC2021655925

Write-up: slight Anaphylaxis; swallowing difficult; Pharynx strangled sensation of; This is a spontaneous report from a contactable physician received from the Regulatory Authority (RA). Regulatory authority report number is v21111778. The patient was 51-year and 9-month female. Body temperature before vaccination was 36.4 degrees Centigrade. The patient had relevant medical history of rhinitis allergic and was receiving medical treatment by oral administration. On 03Jun2021 at 10:15 (the day of vaccination), the patient received the second dose of bnt162b2 (COMIRNATY, Lot number EY5420 and Expiration date 31Aug2021) at the age of 51-year-old. On 03Jun2021, the results of the events were recovered. The details of event were as follows: On 03Jun2021 (the day of vaccination), 30 minutes after the vaccination, the patient experienced swallowing difficult and pharynx strangled sensations of, and the symptoms became progressively stronger. No breathing difficulty, vital signs normal including oxygen saturation (99%). But the symptoms were still ongoing, so the patient received BOSMIN 0.15mg intramuscular injection. After the injection, the symptoms were clearly improved. The reporter classified the event as non-serious and assessed the causality between the event and the vaccines as related. The reporter commented as follows: it was considered as slight anaphylaxis.


VAERS ID: 1411925 (history)  
Form: Version 2.0  
Age: 78.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-03
Onset:2021-06-03
   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 FC3661 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Bradycardia, Dizziness, Heart rate
SMQs:, Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Vestibular disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210603; Test Name: Bradycardia; Result Unstructured Data: Test Result:35-40/min
CDC Split Type: JPPFIZER INC2021656065

Write-up: Bradycardia (35-40/min); swaying feeling; This is a spontaneous report from a contactable physician received from the Regulatory Authority (RA). Regulatory authority report number is v21111717.?? The patient was a 78-year-old male. On 03Jun2021 (the day of vaccination), the patient received?the first dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number FC3661, Expiration date 30Sep2021) via an unspecified route of administration as a single dose for COVID-19 immunization. The patient experienced symptoms on 03Jun2021. The course of the event was as follows: After the vaccination, the condition was observed, the patient said that there was swaying feeling. Although the subjective symptom improved, the patient said that there was bradycardia of 35-40/min. Requested emergency transportation and sent to (a hospital). The reporting physician classified the event as serious (At risk disability) and assessed that the causality between the event and bnt162b2 as unassessable.


VAERS ID: 1411927 (history)  
Form: Version 2.0  
Age: 84.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-27
Onset:2021-06-03
   Days after vaccination:7
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: Asthenia, Body temperature, Hypoaesthesia, Lacunar infarction, Magnetic resonance imaging
SMQs:, Peripheral neuropathy (broad), Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, arterial (narrow), Guillain-Barre syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none
Allergies:
Diagnostic Lab Data: Test Date: 20210527; Test Name: body temperature; Result Unstructured Data: Test Result:35.3 Centigrade; Comments: before vaccination; Test Date: 20210603; Test Name: MRI; Result Unstructured Data: Test Result:Lacunar infarction
CDC Split Type: JPPFIZER INC2021656073

Write-up: Lacunar infarction; numbness of left upper extremities; Difficulty in applying force; This is a spontaneous report from a contactable pharmacist received from the regulatory authority. Regulatory authority report number is v2111179. The patient was an 84-year and 8-month-old male. Body temperature before vaccination was 35.3 degrees Centigrade on 27May2021. 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). Concomitant medications were not provided. On 27May2021 afternoon (the day of vaccination, at the age of 84-year-old), the patient received the first dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number EX3617, Expiration date 31Aug2021) via an unspecified route of administration as a single dose for COVID-19 immunisation. On 03Jun2021 at 08:30 (7 days after the vaccination), the patient experienced Lacunar infarction. On 03Jun2021 (7 days after the vaccination), the patient was admitted to the hospital. The course of the event was as follows: On 27May2021, the patient received vaccination. On 03Jun2021 around 08:30 a.m., the patient experienced numbness of left upper extremities and difficulty in applying force. The patient was observed at home, but the symptoms did not improve and he visited the hospital. The patient had a test of MRI, lacunar infarction was diagnosed and the patient was hospitalized. After hospitalization, the patient was treated via administration. The symptoms was improved compared with the symptoms when the patient was hospitalized. The reporting pharmacist classified the event as serious (Hospitalization) and assessed that the causality between the event and BNT162B2 as unassessed. The outcome of the events was unknown.; Sender''s Comments: Based on the information currently available, the reported events more likely represented intercurrent illnesses for this patient with advanced age, but not 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 RAs, Ethics Committees, and investigators, as appropriate.


VAERS ID: 1411952 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-05-01
Onset:2021-06-03
   Days after vaccination:33
Submitted: 0000-00-00
Entered: 2021-06-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK LA / -

Administered by: Other       Purchased by: ?
Symptoms: Cerebellar 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? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021656680

Write-up: Cerebellar infarction; This is a spontaneous report from a contactable pharmacist received via a Regulatory Authority. The patient was 56-year-old. Whether the patient received any other vaccines within 4 weeks prior to the COVID vaccine was unknown. Whether the patient received any other medications within 2 weeks of vaccination was unknown. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no allergies to medications, food, or other products. The patient had no other medical history. In May2021 of an unspecified date, the patient received the single dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number was unknown because of unable to read the details (as reported)) for COVID-19 immunization. On 03Jun2021 (2 weeks after the vaccination), the patient was hospitalized due to cerebral infarction. Details unknown because the inoculation facility and hospitalization facility were different. The reporter classified the event as serious (hospitalized) and stated the event result in Emergency room/department or urgent care. The outcome of the event was unknown with treatment including Hematoma removal surgery. Since the vaccination, the patient has not been tested for COVID-19. Information on the lot/batch number has been requested; Sender''s Comments: Based on the information currently available, the reported event cerebral infarction more likely represented intercurrent illness, but not 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 RAs, Ethics Committees, and investigators, as appropriate.


VAERS ID: 1411961 (history)  
Form: Version 2.0  
Age: 70.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-31
Onset:2021-06-03
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-06-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: 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? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypercholesterolaemia; Hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021656916

Write-up: Urticaria; This is a spontaneous report from a contactable physician received via COVID-19 Adverse Event Self-Reporting Solution (COVAES). The patient was a non-pregnant 70-year-old female. It was unknown whether the patient receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received Hypertension, Hypercholesterolaemia prescription drugs within 2 weeks of vaccination. It was unknown whether the patient had been diagnosed with COVID-19. On 31May2021(the day of vaccination), the patient received the first single dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number unknown) intramuscular for COVID-19 immunization. On 03Jun2021(the day after vaccination), the patient experienced Urticaria. The reporter stated the event(s) results in doctor or other healthcare professional office/clinic visit. The outcome of the event was not recovered with treatment including Bepotastine Besilate orally. It was unknown whether the patient has been tested for COVID-19 since the vaccination. Information about lot/batch number cannot be obtained.


VAERS ID: 1411980 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-03
Onset:2021-06-03
   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 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, 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? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210603; Test Name: Body temperature; Result Unstructured Data: Test Result:36.5 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC2021658358

Write-up: Anaphylaxis; This is a spontaneous report from a contactable physician received from the Regulatory authority report number is V21111649. The patient was a 35-year and 5-month-old female. Body temperature before vaccination was 36.5 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 03Jun2021 at 13:55 (the day of vaccination), (at age of 35-year-old) the patient received the second 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 immunization. On 03Jun2021 at 14:10 (15 minutes after the vaccination), the patient experienced Anaphylaxis. On 03Jun2021 (the day of vaccination), the patient was admitted to the hospital (physician was Emergency responsible doctor). On unspecified date, the outcome of the event was unknown. The course of the event was as follows: at 13:55 vaccination. Around 14:10, urticaria appeared. After, cough, queasy, a sense of dyspneoa, Palpitations appeared. It was diagnosis as Anaphylaxis and initial response was given. In order to observe the delayed reaction, requested hospital to handle. The reporting physician classified the event as serious(hospitalized) 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: 1412001 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-03
Onset:2021-06-03
   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 EY0779 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210603; Test Name: blood pressure; Result Unstructured Data: Test Result:198/111 mmHg; Comments: at about 16:00; Test Date: 20210603; Test Name: blood pressure; Result Unstructured Data: Test Result:142/90 mmHg; Comments: after 1 hour; Test Date: 20210603; Test Name: Body temperature; Result Unstructured Data: Test Result:36.3 degrees Centigrade; Comments: before the vaccinations
CDC Split Type: JPPFIZER INC2021659044

Write-up: Blood pressure increased/blood pressure was 198/111mmHg; headache; itching of the skin; redness of the skin; This is a spontaneous report from a contactable physician received from the Agency (A). Regulatory authority report number is v21111872. The patient was 49-year and 5-month-old female. Body temperature before the vaccinations was 36.3 degrees Centigrade. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status, etc.). On 03Jun2021 at about 15:00 (the day of vaccinations), the patient received the second dose of bnt162b2(COMIRNATY Intramuscular injection, Lot number: EY0779, expiration date: 31Aug2021). And the event onset date was reported as 03Jun2021 at about 16:00. Clinical course of the event was reported as follows: On 03Jun2021 at about 15:00 (the day of vaccinations), vaccination performed. On 03Jun2021 at about 16:00 (the day of vaccinations), the patient''s blood pressure was 198/111mmHg at above time, the patient experienced headache, itching of the skin occurred, and then redness of the skin occurred. the patient took NIFEDIPINE 5mg orally, blood pressure improved to 142/90mmHg after 1 hour. After prescribing anti-allergic drugs, antihypertensive drugs, and headache drugs, she returned home. On 03Jun2021 (the day of vaccinations), the outcome of the events was recovered. The event term was reported as blood pressure increased. The reporter classified the event as non-serious and assessed the causality between the event and the vaccines as related. There is no other possible cause of the event such as any other diseases. The reporter''s comments: It was thought it was may be an adverse reaction.


VAERS ID: 1412002 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-03
Onset:2021-06-03
   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 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Dyspnoea, Hypoaesthesia oral, Pruritus, Swelling
SMQs:, Anaphylactic reaction (narrow), Angioedema (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), 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: Medical History/Concurrent Conditions: Atopy; Food allergy
Allergies:
Diagnostic Lab Data: Test Date: 20210603; Test Name: body temperature; Result Unstructured Data: Test Result:36.4 Centigrade; Comments: Before vaccination
CDC Split Type: JPPFIZER INC2021659067

Write-up: Dyspnoea; Numbness of lips; itching; swelling; This is a spontaneous report from the contactable physician received from the Regulatory Authority. The Regulatory authority report number is v21111760. The patient was 28-year-old female. Body temperature before the vaccinations was 36.4 degrees centigrade on 03Jun2021. The patient''s history according to the Vaccine Screening Questionnaire was atopy, allergy to shrimp, crab, squid. The patient''s concomitant drug was not provided. On 03Jun2021 at 14:00 (the day of vaccination, at the age of 28-year-old), the patient received the first dose of BNT162B2 (COMIRNATY, Intramuscular injection, Lot number: EY2173, expiration date: 31Aug2021), via an unspecified route of administration as a single dose for COVID-19 immunisation. On 03Jun2021 at 14:05 (the day of vaccination), the patient experienced dyspnoea, numbness of lips, itching. The outcome of the event was recovering on 03Jun2021 (The day of vaccination). Clinical course of the event was reported as follows: The patient experienced dyspnoea, numbness of lips, swelling a few minutes after vaccination. In addition, before vaccination, the patient did not eat meat that can cause allergy. So the relationship assessed as related. After administration of antihistamine, the symptoms was recovering. The reporter classified the event as non-serious and the causality between the event and the vaccines was Related. Other possible cause of the event such as any other diseases was no.


VAERS ID: 1412006 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-03
Onset:2021-06-03
   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 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Bedridden, Dysarthria, Pain in extremity, Thalamus haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Tendinopathies and ligament 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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021659284

Write-up: haemorrhage brain/right thalamus haemorrhage; dysarthria; unable to get up normally; pain in the left upper limb; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21111780. The patient was an 85-year and 3-month-old male. Body temperature before vaccination was not provide. The patient''s family history was unknown and patient''s 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.) included unknown, no fever occurred. On 03Jun2021 at 15:00 (the day of vaccination), the patient received the first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number FA2453, Expiration date 31Aug2021) at the age of 85-year-old via an unspecified route of administration as a single dose for COVID-19 immunization. Before 04Jun2021 at 08:30 (17 hours 30 minutes after the vaccination), the patient experienced haemorrhage brain. On 04Jun2021 at about 08:30 (17 hours 30 minutes after the vaccination), the patient was admitted to the hospital. The outcome of the event was not provide. The course of the event was as follows: On 03Jun2021, the first vaccination was carried out. The patient complained of pain in the left upper limb on the same night. On 04Jun2021 at about 08:30 a.m, when patient''s daughter spoke, the patient had dysarthria and was unable to get up normally. After observation, the symptoms did not improve, so asked for emergency aid. He was transferred to hospital and diagnosed as right thalamus haemorrhage. The reporting physician classified the event as serious (Hospitalized) and assessed the causality between the event and bnt162b2 as un-assessable. Other possible causes of the event such as any other diseases was hypertension. The reporting physician commented as follows: not provided.


VAERS ID: 1412007 (history)  
Form: Version 2.0  
Age: 63.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-03
   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 - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Infection, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (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: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none
Allergies:
Diagnostic Lab Data: Test Date: 20210603; Test Name: body temperature; Result Unstructured Data: Test Result:37.9 Centigrade; Comments: after vaccine; Test Date: 20210605; Test Name: body temperature; Result Unstructured Data: Test Result:39.9 Centigrade; Comments: after vaccine
CDC Split Type: JPPFIZER INC2021659333

Write-up: Medical history was none. concomitant medication was not reported. The details of the reaction was reported as follow: The patient received the BNT162B2(COMIRNATY intramuscular injection, Lot number: unknown, Expiration date: unknown) on 02Jun2021 for COVID-19 immunisation. On 03Jun2021, the patient experienced pyrexia 37.9 degree centigrade, on 05Jun2021, the patient experienced pyrexia up to 39.9 degree centigrade. From pyrexia started, it lasted for a week. At the time of got information, pyrexia dropped and there was no problem. It was considered as Infection NOS caused by CMT vaccination. Additional information: Patients have no basic disease or concomitant drug. This event was found after using the product. The outcome of events was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender''s Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of infection and pyrexia. There is limited information provided in this report. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.


VAERS ID: 1412017 (history)  
Form: Version 2.0  
Age: 87.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-24
Onset:2021-06-03
   Days after vaccination:10
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: Body temperature, Pneumonia, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210603; Test Name: body temperature; Result Unstructured Data: Test Result:38.1 Centigrade; Test Date: 20210603; Test Name: body temperature; Result Unstructured Data: Test Result:between 37 and 37.9 Centigrade; Comments: in the evening
CDC Split Type: JPPFIZER INC2021660401

Write-up: Pneumonia; pyrexia of 38.1 degrees Centigrade; This is a spontaneous report received from a contactable pharmacist via a Pfizer sales representative. An 87-year-old female patient received first dose of bnt162b2 (COMIRNATY), via an unspecified route of administration on 24May2021 (Batch/Lot number was not reported) at age of 87-year-old as single dose for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 03Jun2021, after bnt162b2, the patient experienced pneumonia and pyrexia of 38.1 degrees Centigrade and was hospitalized on the same day. Cephem antibiotics were administered and body temperature improved to the level between 37 and 37.9 degrees Centigrade in the evening. The outcome of event was recovering. Seriousness and causality of the events were not provided. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender''s Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of pneumonia and pyrexia. There is limited information provided in this report. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.


VAERS ID: 1412112 (history)  
Form: Version 2.0  
Age: 62.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-30
Onset:2021-06-03
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-06-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Bell's palsy
SMQs:, Hearing impairment (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: METFORMIN
Current Illness: Diabetes (treated with metformin.)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PEPFIZER INC2021709676

Write-up: Bell''s palsy; This is a spontaneous report from a contactable physician (patient''s brother-in-law) received through Medical Information Team. A 62-year-old male patient received first dose of BNT162B2 (COMIRNATY; Solution for injection; Batch/Lot number was unknown), intramuscular on 30May2021 as first dose, single dose (at the age of 62-year-old) for COVID-19 immunisation. Medical history included ongoing diabetes from 2018 (start date reported as: 3 years ago). Concomitant medications included ongoing metformin at 850 mg, oral, 1 daily, taken for diabetes mellitus from 2018 (start date reported as: 3 years ago). The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. After 8 days, on 03Jun2021, the patient started to experience right-sided facial paralysis, which was diagnosed as Bell''s palsy by a neurologist. The neurologist considered that the event might be related to the vaccine; therefore, the reporter wanted to know if the patient should receive the second dose of the vaccine or what to do. Reporter (physician) described the event as abrupt onset: the day before (02Jun2021), the patient was normal; then, he went to sleep and the following day (03Jun2021) he noticed difficulty in spitting. On 05Jun2021, the patient was seen by a neurologist, who, based on the physical examination and the symptoms, diagnosed the patient with Bell''s palsy. The neurologist indicated the following oral treatment: prednisone for 5 days; acyclovir for 7 days; DUO CVPK. The patient started the treatment indicated by the neurologist on 05Jun2021 and 3 or 4 days after starting the treatment, improvement was evidenced. At the time of this report, the patient was recovered at 70%: the patient still has the right face down, the pain disappeared, and he could close the right eye. The neurologist considered that the event might be related to the vaccine. Reporter further wanted to know if the patient should receive the second dose of the vaccine or what to do. The outcome of event was recovering. Information on the lot/batch number has been requested.; Sender''s Comments: Based on close temporal relationship the causal association between the reported event bell''s palsy with the usage of the vaccine BNT162B2 cannot be excluded. The case will be reassigned if there is any new information available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.


VAERS ID: 1412115 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-03
Onset:2021-06-03
   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 FD0932 / 1 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Blood pressure decreased, Body temperature decreased, Cold sweat, Dizziness, Laryngeal oedema, Nausea, Somnolence
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Hypersensitivity (narrow), Hypoglycaemia (broad), Dehydration (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: COVID-19
Allergies:
Diagnostic Lab Data:
CDC Split Type: PLPFIZER INC2021656394

Write-up: 20 minutes after receiving the first dose, there was a sudden drop in temperature and blood pressure, cold sweat, laryngeal edema, nausea, dizziness, weakness, drowsiness.; 20 minutes after receiving the first dose, there was a sudden drop in temperature and blood pressure, cold sweat, laryngeal edema, nausea, dizziness, weakness, drowsiness.; 20 minutes after receiving the first dose, there was a sudden drop in temperature and blood pressure, cold sweat, laryngeal edema, nausea, dizziness, weakness, drowsiness.; 20 minutes after receiving the first dose, there was a sudden drop in temperature and blood pressure, cold sweat, laryngeal edema, nausea, dizziness, weakness, drowsiness.; 20 minutes after receiving the first dose, there was a sudden drop in temperature and blood pressure, cold sweat, laryngeal edema, nausea, dizziness, weakness, drowsiness.; 20 minutes after receiving the first dose, there was a sudden drop in temperature and blood pressure, cold sweat, laryngeal edema, nausea, dizziness, weakness, drowsiness.; 20 minutes after receiving the first dose, there was a sudden drop in temperature and blood pressure, cold sweat, laryngeal edema, nausea, dizziness, weakness, drowsiness.; 20 minutes after receiving the first dose, there was a sudden drop in temperature and blood pressure, cold sweat, laryngeal edema, nausea, dizziness, weakness, drowsiness.; This is as spontaneous report received from a contactable consumer (patient) via a regulatory authority. Safety report unique identifier is PL-COVAES-51fb5d66-86a9-4075-968b-c90b16e25c3c. A 27-year-old female patient received first dose bnt162b2 (COMIRNATY, Batch/Lot Number: FD0932), via an unspecified route of administration, administered in left arm on 03Jun2021 19:00 at the age of 27-year-old as single dose for covid-19 immunization. Medical history included covid-19 from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. The patient experienced 20 minutes after receiving the first dose, there was a sudden drop in temperature and blood pressure, cold sweat, laryngeal edema, nausea, dizziness, weakness, drowsiness on 03Jun2021 19:15. The adverse event result in doctor or other healthcare professional office/clinic visit. The outcome of events were resolving. Facility where the most recent COVID-19 vaccine was administered was hospital. The patient didn''t receive any other vaccines within 4 weeks prior to the COVID vaccine. There was no any other medications the patient received within 2 weeks of vaccination. Since the vaccination, the patient has not been tested for COVID-19. No follow-up attempts possible. No further information expected.


VAERS ID: 1412116 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-03
   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 - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Headache, Malaise, Mood altered, Nausea, Pain in extremity, Pyrexia, Suspected COVID-19
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Depression (excl suicide and self injury) (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20210603; Test Name: body temp; Result Unstructured Data: Test Result:up to 39.1 Centigrade
CDC Split Type: PLPFIZER INC2021664304

Write-up: This is a spontaneous report received from a non-contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (COMIRNATY), via an unspecified route of administration on 02Jun2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included covid-19 in Mar2021. The patient''s concomitant medications were not reported. The patient had this vaccine yesterday (02Jun2021) and today (03Jun2021) she had very high fever, nausea, fever up to 39 and 1 degree, headache, malaise, very bad mood, pain in her hand and she felt as if she had COVID infection. The outcome of the events was unknown. No follow-up attempts possible. Batch/lot number was not provided and cannot be obtained.


VAERS ID: 1412172 (history)  
Form: Version 2.0  
Age: 44.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-03
   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 FA8016 / 2 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Dysmenorrhoea, Myalgia, Postmenopausal haemorrhage
SMQs:, Rhabdomyolysis/myopathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Eosinophilic pneumonia (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: LEVAXIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetes; Hypothyroidism; Peanut allergy
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC2021655788

Write-up: menstrual pain and bleeding, not have menstruation since two years back; strong muscle pain in all joints; menstrual pain and bleeding; This is a spontaneous report from a contactable consumer (patient). A 44-year-old female patient received bnt162b2 (COMIRNATY) via an unspecified route of administration, administered in arm left on 02Jun2021 15:15 (Lot Number: FA8016) (at the age of 44 years old) as 2nd dose, single for COVID-19 immunisation. Patient was not pregnant at time of vaccination. The patient had not received any other vaccine within 4 weeks. Medical history included low thyroid production, diabetes, and peanut allergy. Concomitant medication included levothyroxine sodium (LEVAXIN). The patient previously took amoxicillin trihydrate (AMIMOX) and experienced allergic reaction (ending up in hospital); she had also reacted to some other drugs (not further specified); she received the first dose of bnt162b2 (batch/lot number EW4815) on 21Apr2021 at 19:30 (at the age of 44 years old) in right arm for COVID-19 immunisation. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. The patient experienced menstrual pain and bleeding, not have menstruation since two years back on 03Jun2021 05:00, strong muscle pain in all joints on 03Jun2021 05:00, menstrual pain and bleeding on 03Jun2021 05:00. The pain was like when giving birth. No treatment was given for the events. The outcome of the events was recovered. No follow-up attempts are possible. No further information expected.


VAERS ID: 1412182 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-05-28
Onset:2021-06-03
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-06-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Coagulation test, Computerised tomogram, Electrocardiogram, Full blood count, Musculoskeletal chest pain, Myalgia, Pneumonia, SARS-CoV-2 test negative
SMQs:, Rhabdomyolysis/myopathy (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210608; Test Name: Coagulation test; Result Unstructured Data: Test Result:blood coagulation was above the reference value; Test Date: 20210605; Test Name: tomography; Result Unstructured Data: Test Result:unknown; Test Date: 20210608; Test Name: tomography; Result Unstructured Data: Test Result:unknown; Comments: No clot was observed in the medicated tomography.; Test Date: 20210605; Test Name: EKG; Result Unstructured Data: Test Result:unknown; Test Date: 20210608; Test Name: EKG; Result Unstructured Data: Test Result:unknown; Test Date: 20210605; Test Name: full blood; Result Unstructured Data: Test Result:unknown; Test Date: 20210608; Test Name: full blood; Result Unstructured Data: Test Result:unknown; Comments: It was observed that blood coagulation was above the reference value, besides, it was determined that the infection value in the blood was quite high.; Test Name: covid-19 test; Test Result: Negative
CDC Split Type: TRPFIZER INC2021705584

Write-up: pneumonia; Muscle pain; pain in left rib cage; This is a spontaneous report from a contactable consumer or other non hcp through Pfizer Business Partner. A 24-year-old patient of an unspecified gender received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on 28May2021 at single dose for COVID-19 immunisation. Relevant medical history and concomitant medications were not reported. On 03Jun2021 the patient felt severe pain in left rib cage, went to the hospital on 05Jun2021 and after ECG, whole blood and tomography tests was diagnosed with muscle pain and was sent home to be given pain reliever. As the pain worsened, the patient went back to the hospital on 08Jun2021 and underwent ECG, whole blood and medicated tomography tests. As a result of the tests, it was seen that the blood coagulation was above the reference value, besides, it was determined that the infection value in the blood was quite high. No clot was observed in the medicated tomography. The patient was discharged with the diagnosis of pneumonia with a drug called Avelox. Covid-19 test was negative. Outcome of the events was unknown.


VAERS ID: 1413647 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-03
Onset:2021-06-03
   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: Dry throat, Fatigue, Feeling hot, Headache, Maternal exposure during breast feeding, Myalgia, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Eosinophilic pneumonia (broad), Neonatal exposures via breast milk (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:
Current Illness: Breast feeding
Preexisting Conditions: Medical History/Concurrent Conditions: Clinical trial participant; Lactation decreased; Comments: Still breastfeeding Patient has not had symptoms associated with COVID-19 Patient is not pregnant
Allergies:
Diagnostic Lab Data: Test Date: 20210520; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: clinical trial participant Study details: regulatory authority covid study.
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Maternal exposure during breast feeding; Dry throat; Headache; Fatigue; Muscle ache; felt hot; This regulatory authority case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding), DRY THROAT (Dry throat), HEADACHE (Headache), FATIGUE (Fatigue) and MYALGIA (Muscle ache) in a 32-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Still breastfeeding Patient has not had symptoms associated with COVID-19 Patient is not pregnant. The patient''s past medical history included Lactation decreased and Clinical trial participant. Concurrent medical conditions included Breast feeding. On 03-Jun-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 03-Jun-2021, the patient experienced DRY THROAT (Dry throat) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant), FATIGUE (Fatigue) (seriousness criterion medically significant), MYALGIA (Muscle ache) (seriousness criterion medically significant) and FEELING HOT (felt hot). On an unknown date, the patient experienced MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding) (seriousness criterion medically significant). At the time of the report, MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding) and FEELING HOT (felt hot) outcome was unknown and DRY THROAT (Dry throat), HEADACHE (Headache), FATIGUE (Fatigue) and MYALGIA (Muscle ache) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-May-2021, SARS-CoV-2 test: no - negative covid-19 test (Negative) clinical trial participant Study details: regulatory authority covid study.. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. 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. Reporter did not allow further contact; 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: 1413659 (history)  
Form: Version 2.0  
Age: 59.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-03
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002614 / 1 LA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Burning sensation, Chest discomfort, Erythema, Peripheral swelling, Pruritus, Rash, Skin oedema
SMQs:, Cardiac failure (broad), Anaphylactic reaction (narrow), Angioedema (broad), Peripheral neuropathy (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: METHOTREXATE; FOLICIL; DEFLAZACORTE; OMEPRAZOLE
Current Illness: Autoimmune thyroiditis; Psoriatic arthritis
Preexisting Conditions: Medical History/Concurrent Conditions: Wasp sting
Allergies:
Diagnostic Lab Data:
CDC Split Type: PTMODERNATX, INC.MOD20212

Write-up: Light glottis pressure; Rash (at areas on hands and armpits previously stung by wasp); Pain in the hands and feet''s joints; Hand and the armpit area started to swell; After the vaccine, the same areas turned red again, as if it had just been bitten; Edema (at areas on hands and armpits previously stung by wasp); Itching (at areas on hands and armpits previously stung by wasp); Burning sensation (at areas on hands and armpits previously stung by wasp); This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Hand and the armpit area started to swell), ERYTHEMA (After the vaccine, the same areas turned red again, as if it had just been bitten), SKIN OEDEMA (Edema (at areas on hands and armpits previously stung by wasp)), PRURITUS (Itching (at areas on hands and armpits previously stung by wasp)) and BURNING SENSATION (Burning sensation (at areas on hands and armpits previously stung by wasp)) in a 59-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3002614) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Wasp sting on 27-May-2021. Concurrent medical conditions included Autoimmune thyroiditis and Psoriatic arthritis. Concomitant products included METHOTREXATE, FOLIC ACID (FOLICIL), DEFLAZACORT (DEFLAZACORTE) and OMEPRAZOLE for an unknown indication. On 02-Jun-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 03-Jun-2021, the patient experienced PERIPHERAL SWELLING (Hand and the armpit area started to swell) (seriousness criterion medically significant), ERYTHEMA (After the vaccine, the same areas turned red again, as if it had just been bitten) (seriousness criterion medically significant), SKIN OEDEMA (Edema (at areas on hands and armpits previously stung by wasp)) (seriousness criterion medically significant), PRURITUS (Itching (at areas on hands and armpits previously stung by wasp)) (seriousness criterion medically significant), BURNING SENSATION (Burning sensation (at areas on hands and armpits previously stung by wasp)) (seriousness criterion medically significant), RASH (Rash (at areas on hands and armpits previously stung by wasp)) and ARTHRALGIA (Pain in the hands and feet''s joints). On 04-Jun-2021, the patient experienced CHEST DISCOMFORT (Light glottis pressure). The patient was treated with HYDROCORTISONE (intravenous) at a dose of 1 dosage form; CLEMASTINE at a dose of 1 dosage form and DESLORATADINE (AERIUS [DESLORATADINE]) at a dose of 0.5 milligram, to be taken at home. At the time of the report, PERIPHERAL SWELLING (Hand and the armpit area started to swell) and RASH (Rash (at areas on hands and armpits previously stung by wasp)) was resolving and ERYTHEMA (After the vaccine, the same areas turned red again, as if it had just been bitten), SKIN OEDEMA (Edema (at areas on hands and armpits previously stung by wasp)), PRURITUS (Itching (at areas on hands and armpits previously stung by wasp)), BURNING SENSATION (Burning sensation (at areas on hands and armpits previously stung by wasp)), CHEST DISCOMFORT (Light glottis pressure) and ARTHRALGIA (Pain in the hands and feet''s joints) outcome was unknown. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) was unknown. Products known to have been used by the patient, within two weeks prior to the event, included Lexonomide 20 mg daily. Patient reported using concomitant medication was to treat autoimmune thyroiditis and arthritis psoriatic. Company Comment: This case concerns a 59-year-old female with serious unexpected events of peripheral swelling, erythema, skin oedema, pruritus, and burning sensation, and non-serious chest discomfort, rash, and arthralgia. Event latency 32 hours after first dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender''s Comments: This case concerns a 59-year-old female with serious unexpected events of peripheral swelling, erythema, skin oedema, pruritus, and burning sensation, and nonserious chest discomfort, rash, and arthralgia. Event latency 32 hours after first dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.


VAERS ID: 1414815 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-06-03
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: Seizure
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), 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: AUPFIZER INC2021678842

Write-up: seizure; This is a spontaneous report from a contactable other health professional received via the Regulatory Authority. Regulatory authority report number is 564232. A 59-year-old female patient received BNT162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced seizure on 03Jun2021 with outcome of recovered. No follow-up attempts are possible, information about lot/batch number cannot be obtained.


VAERS ID: 1415585 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-03
Onset:2021-06-03
   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 - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Anal haemorrhage, Diarrhoea, Haemorrhage, SARS-CoV-2 test
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Pseudomembranous colitis (broad), Gastrointestinal haemorrhage (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Noninfectious diarrhoea (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Acid reflux (esophageal); Lactation decreased; Vitamin D deficiency
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021657556

Write-up: bleeding; Anal bleeding; Diarrhoea; 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-APPCOVID-20210604095402, Safety Report Unique Identifier GB-MHRA-ADR 25418964. A 33-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 03Jun2021 (Lot number was not reported), vaccination at 33 years, as unknown, single dose for COVID-19 immunization. Medical history included Lactation decreased, Acid reflux (esophageal) and Vitamin D. Patient has not had symptoms associated with COVID-19. Patient was not enrolled in clinical trial. Patient was not pregnant or currently breastfeeding. The patient''s concomitant medications were not reported. The patient previously took vitamin d [colecalciferol] and folic acid. The patient experienced bleeding on an unspecified date, anal bleeding on 03Jun2021, diarrhoea on 03Jun2021. The patient bleeding a fair amount every time i the toilet (as reported). The patient underwent lab tests and procedures which included COVID-19 virus test: No - Negative COVID-19 test on unspecified date. The outcome of event bleeding was unknown, others was not recovered. This case was reported as not serious. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1415586 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-03
Onset:2021-06-03
   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 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest discomfort, Chest pain, Dyspnoea, Heart rate, Heart rate increased, Hypertension, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Hypertension (narrow), Cardiomyopathy (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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20210603; Test Name: a small walk to bathroom takes its o 130+; Result Unstructured Data: Test Result:130+; Test Date: 20210603; Test Name: Resting heart rate; Result Unstructured Data: Test Result:105; Test Date: 20210603; Test Name: while doing something remotely more physiological such as wiping the dining table take it to 150+; Result Unstructured Data: Test Result:150+; Test Date: 20201116; Test Name: COVID-19 virus test; Test Result: Positive ; Comments: Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC2021657207

Write-up: shortness of breath; Hypertension; resting heart rate and blood preachers started to increase; Severe chest discomfort/heart; Severe chest discomfort/heart/mall walk to bathroom takes it to 130+ while doing something remotely more physiological such as wiping the dining table take it to 150+; This is a spontaneous report from a contactable consumer received from the Agency Regulatory Authority. The regulatory authority report number is GB-MHRA-APPCOVID-20210605071402, Safety Report Unique Identifier GB-MHRA-ADR 25425069. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Et8885, expiry date not reported), via an unspecified route of administration on 03Jun2021 as unknown dose number, single for COVID-19 immunisation. Medical history included suspected COVID-19 from 14Nov2020 to 05Jan2021. Patient is not enrolled in clinical trial. The patient''s concomitant medications were not reported. The patient experienced shortness of breath and hypertension on 03Jun2021. It was reported that resting heart rate and blood preachers started to increase immediately after vaccine however on the reported data patient feel slight shortness of breath and discomfort in heart when doing the smallest of activities. Resting heart rate is 105 and a small walk to bathroom takes it to 130+ while doing something remotely more physiological such as wiping the dining table take it to 150+ with severe discomfort of the chest/heart. Watch taking constant heart rate readings and showing high heart rate warning. The events were reported as serious (Other medically important condition). The patient underwent lab tests and procedures which included COVID-19 virus test: positive (yes - positive COVID-19 test) on 16Nov2020. The patient had not recovered from hypertension, recovering from shortness of breath, while outcome of the remaining events was unknown. No follow-up attempts are Possible. No further information is expected.


VAERS ID: 1415590 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-03
Onset:2021-06-03
   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 E003143 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Back pain, Maternal exposure during pregnancy, Muscle spasms, Primigravida, SARS-CoV-2 test, Vaginal haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Retroperitoneal fibrosis (broad), Dystonia (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow), Normal pregnancy conditions and outcomes (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ELLESTE-SOLO; FOLIC ACID; PREGNACARE ORIGINAL [ASCORBIC ACID;BETACAROTENE;BIOTIN;CALCIUM PANTOTHENATE;COLECALCIFEROL;COPPER;CY; UTROGESTAN
Current Illness: Pregnancy
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased; Miscarriage
Allergies:
Diagnostic Lab Data: Test Date: 20210604; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021657922

Write-up: miscarriage; first pregnancy; Early miscarriage; Vaginal bleeding; Cramps; Low back ache; Maternal exposure during pregnancy; This is a spontaneous report from a contactable consumer received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-APPCOVID-20210605192632, Safety Report Unique Identifier GB-MHRA-ADR 25426369. A 36-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: E003143)via an unspecified route of administration at single dose on 03Jun2021 at the age of 36 years old for COVID-19 immunisation. Medical history included miscarriage, lactation decreased, ongoing pregnancy. Patient has not had symptoms associated with COVID-19. Patient is not enrolled in clinical trial. Patient is not currently breastfeeding. Concomitant medications included estradiol (ELLESTE-SOLO) taken for IVF support from 19Apr2021; folic acid (Manufacturer unknown) taken for folic acid supplementation at 400 ug; ascorbic acid, betacarotene, biotin, calcium pantothenate, colecalciferol, copper, cyanocobalamin, folic acid, iodine, iron, magnesium, nicotinamide, phytomenadione, pyridoxine hydrochloride, riboflavin, selenium, thiamine mononitrate, tocopheryl acid succinate, zinc (PREGNACARE ORIGINAL) taken for pregnancy vitamins from 22May2021; progesterone (UTROGESTAN) taken for IVF support from 06May2021. The patient experienced miscarriage on an unspecified date, early miscarriage on 05Jun2021, first pregnancy on an unspecified date, maternal exposure during pregnancy on 03Jun2021, vaginal bleeding on 04Jun2021, cramps on 04Jun2021, low back ache on 04Jun2021. The events were serious as medically significant. The clinical course was reported as follows: The day after the first dose of vaccine was administered the patient started having cramps in her low abdomen, ache in the low back, and brown vaginal spotting. The day after the patient had a more intensive, red, bleeding. The patient was 7 weeks pregnant, and the patient was suspecting that the vaccine might have caused this bleeding/aches and potentially miscarriage(?). The patient was yet to confirm if she has had a miscarriage (it is Saturday evening and the patient was unable to get hold of anyone on the phone or via email). The patient was first pregnancy via IVF. Patient was exposed to the medicine first-trimester (1-12 weeks). The patient underwent lab test included COVID-19 virus test: Negative(No - Negative COVID-19 test) on 04Jun2021. The outcome of the events first pregnancy, miscarriage was recovering, of the event Maternal exposure during pregnancy was unknown, of the events Vaginal bleeding, Cramps, Low back ache, Early miscarriage was not recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1415607 (history)  
Form: Version 2.0  
Age: 47.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-03
Onset:2021-06-03
   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 EW,109 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Vision blurred
SMQs:, Anticholinergic syndrome (broad), Glaucoma (broad), Lens disorders (broad), Retinal 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: DIPROSALIC
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Eczema; Suspected COVID-19
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021657435

Write-up: Hazy vision; This is a spontaneous report from a contactable consumer, received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202106031201534720-MAWT8, Safety Report Unique Identifier GB-MHRA-ADR 25420957. A 47-year-old male patient received the first dose of BNT162B2 (Pfizer-BIONTECH COVID-19 Vaccine), via an unspecified route of administration on 03Jun2021 (at the age of 47-years-old) (Batch/Lot Number: EW,109) as a single dose for COVID-19 immunization. Medical history included suspected COVID-19 from 29Dec2019 to 14Jan2020 and eczema. The patient has not had a COVID-19 test and was not enrolled in a clinical trial. Concomitant medications included betamethasone dipropionate, salicylic acid (DIPROSALIC) taken for eczema and an unspecified medication (described as being applied to the patient''s scalp and was applied the day before having the vaccine). The patient experienced hazy vision on 03Jun2021 which started approximately 20 minutes after receiving the injection. The patient has not tested positive for COVID-19 since having the vaccine. Outcome of the event was not recovered. The case was reported as serious (medically significant). No follow-up attempts are possible. No further information is expected.


VAERS ID: 1415621 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-03
   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: Abdominal pain, Dysmenorrhoea, Headache, Nausea
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021657697

Write-up: abdominal pain; Painful periods; Headache; Nausea; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202106040910078540-IX13B. Safety Report Unique Identifier: GB-MHRA-ADR 25418903. A 33-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 02Jun2021 (Lot Number: EW3143) as single dose for covid-19 immunization. Medical history included suppressed lactation. The patient''s concomitant medications were not reported. The patient experienced abdominal pain on an unspecified date with outcome of recovering, painful periods on 03Jun2021 with outcome of not recovered, headache and nausea on 03Jun2021 with outcome of recovering. Took paracetamol which seemed to have somewhat relieve the headache, but the abdominal pain still persists. Seriousness criteria reported as medical significant. 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. Patient has not tested positive for COVID-19 since having the vaccine No follow-up attempts are needed. No further information is expected.


VAERS ID: 1415624 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-03
Onset:2021-06-03
   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: Neck pain
SMQs:, Arthritis (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: SERTRALINE
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021657638

Write-up: Neck pain; This is a spontaneous report from a contactable consumer received from the regulatory authority report number is GB-MHRA-WEBCOVID-202106040933065870-ZJNPF, Safety Report Unique Identifier GB-MHRA-ADR 25418928. A 33-year-old male patient received BNT162B2, dose 1 via an unspecified route of administration on 03Jun2021 (Lot Number: ET8885) as single dose for COVID-19 immunisation. The patient medical history was not reported. Patient had not had symptoms associated with COVID-19. Not had a COVID-19 test, patient was not enrolled in clinical trial. Concomitant medication included sertraline taken for an unspecified indication from 10Mar2020 to an unspecified stop date. The patient experienced neck pain on 03Jun2021 with outcome of not recovered. Event description: Neck pain developed approx 12 hours after injection, jab delivered in right arm. Pain was too much to be able to turn his head to the right. Pain can often feel sharp and stabbing. Patient had not tested positive for COVID-19 since having the vaccine. This is a serious medically significant case provided by Regulatory Authority assessed by reporter. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1415633 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-03
Onset:2021-06-03
   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, Neck pain, Pain in extremity, SARS-CoV-2 test, Vaccination site erythema, Vaccination site pain
SMQs:, Arthritis (broad), Tendinopathies and ligament disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: SERTRALINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anxiety; 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 INC2021657339

Write-up: This is a spontaneous report from a contactable consumer received from the Regulatory Agency. A 37-year-old female patient received bnt162b2, via unspecified route of administration on 03Jun2021 (batch/lot number and expiry date unknown) at 37 years of age as 1st dose, single for covid-19 immunization. Medical history included suppressed lactation, anxiety. Concomitant medications included sertraline taken for anxiety from 01Jul2018 to an unspecified stop date. On 03Jun2021, the patient experienced painful arm, "aching deep pain around injection site" (vaccination site erythema), aching deep pain around injection site. The patient informed that she experienced aching deep pain around injection site, spread through arm from wrist to neck during the following few hours. 24 hours after injection ache reducing and more localized. The events were reported serious as other medically important condition. The patient underwent lab tests and procedures which included COVID-19 virus test: no - negative covid-19 test on unspecified date. The patient has not tested positive for COVID-19 since having the vaccine. The outcome of the events was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1415635 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-03
Onset:2021-06-03
   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: Body temperature, Confusional state, Dizziness, Generalised tonic-clonic seizure, Loss of consciousness, Pyrexia
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (narrow), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: SERTRALINE HYDROCHLORIDE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Depression mental
Allergies:
Diagnostic Lab Data: Test Name: temperature; Result Unstructured Data: Test Result:high
CDC Split Type: GBPFIZER INC2021657566

Write-up: dizzy; temperature raised very high; blacked out; feeling very confused; Seizure grand mal; This is a spontaneous report. A 37-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 03Jun2021 (Lot Number: Ew3143), at the age of 37 years, as the 1st dose, single for COVID-19 immunisation. Medical history included depression mental. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient is not enrolled in clinical trial. Concomitant medication included sertraline hydrochloride taken for depression from 24Dec2018. The patient experienced blacked out, temperature raised very high, and dizzy on an unspecified date; and seizure grand mal on 03Jun2021. Events described as follows: felt dizzy, blacked out for 3 minutes then feeling very confused to what happened when coming back round and temperature raised very high. The events caused hospitalization and considered medically significant. The patient has recovered from seizure grand mal on 03Jun2021 and outcome of the remaining events was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1415641 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-03
Onset:2021-06-03
   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: Chest pain, SARS-CoV-2 test
SMQs:, Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (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 INC2021657597

Write-up: Chest pain/Chest pain near my heart as soon as I do something physically demanding or breathe heavily; This is a spontaneous report from a contactable consumer (patient) received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202106041105543350-4ZXSK, Safety Report Unique Identifier GB-MHRA-ADR 25419370. A 34-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 03Jun2021 (at the age of 34-year-old) (Lot number was not reported) as first dose, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Patient is not enrolled in clinical trial. On 03Jun2021, the patient experienced chest pain, which was reported as serious medically significant. Patient stated had chest pain near his heart as soon as he do something physically demanding or breathe heavily. The patient underwent lab tests and procedures which included COVID-19 virus test: negative (No - Negative COVID-19 test) on an unspecified date. The outcome of the event was not recovered. Patient has not 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: 1415645 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-03
Onset:2021-06-03
   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: Body temperature, Chills, Maternal exposure during pregnancy, Myalgia, Pyrexia, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ASPIRIN; BISOPROLOL; FOLIC ACID
Current Illness: Pregnancy
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased; Comments: Patient has not had symptoms associated with COVID-19 Patient is not enrolled in clinical trial Patient is not currently breastfeeding
Allergies:
Diagnostic Lab Data: Test Date: 20210603; Test Name: Body temperature; Result Unstructured Data: Test Result:37-37.3 Centigrade; Comments: 10:50 low grade fever; Test Date: 202106; Test Name: Body temperature; Result Unstructured Data: Test Result:38.6 Centigrade; Comments: kept increasing to a max of 38.6; Test Date: 202106; Test Name: Body temperature; Result Unstructured Data: Test Result:37.5 Centigrade; Comments: decreased to 37.5 after taking paracetamol; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021657425

Write-up: Low grade fever 37-37.3/kept increasing to a max of 38.6 and then decreased to 37.5 after taking paracetamol; shivers; Maternal exposure during pregnancy; muscle pain/Muscle ache; This is a spontaneous report from a contactable consumer received from a regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202106041133163330-EXVSN. A 28-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 03Jun2021 (Batch/Lot Number: ET8885) as single dose for COVID-19 immunization. Medical history included suppressed lactation from an unknown date and unknown if ongoing, ongoing pregnancy. Concomitant medications included aspirin taken for pregnancy from Feb2021 to an unspecified date; bisoprolol from Sep2020 to an unspecified date; folic acid taken for vitamin supplementation. The patient experienced maternal exposure during pregnancy on 03Jun2021 with outcome of unknown, muscle pain on 03Jun2021 with outcome of recovering, muscle ache on 04Jun2021 with outcome of recovering, fever on an unspecified date in Jun2021 with outcome of recovering, low grade fever on 03Jun2021 10:50 with outcome of recovering, high temperature on 04Jun2021 with outcome of recovering, shivers on 03Jun2021 with outcome of recovering, chills on 04Jun2021 with outcome of recovering, shivering on 04Jun2021 with outcome of recovering, all reported as medically significant. Clinical course reported as follow: About 12 hours after having the vaccine (10:50 on 03Jun2021) patient experienced low grade fever 37-37.3 which presented with shivers, muscle pain and chills. Her temperature kept increasing to a max of 38.6 and then decreased to 37.5 after taking paracetamol. The low grade fever of 37-37.3 remains still along with muscle aches and chills. Patient was exposed to the medicine third-trimester (29-40 weeks). Patient has 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. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1415646 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-03
Onset:2021-06-03
   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-L690 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Myalgia, Paraesthesia, SARS-CoV-2 test, Vaccination site pain
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210520; Test Name: COVID-19 virus test; Test Result: Negative; Comments: Negative.
CDC Split Type: GBPFIZER INC2021657803

Write-up: muscle pain; pins and needles; Muscle ache; muscle pain at the injection site; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202106041141474890-Y3M1N. Safety Report Unique Identifier is GB-MHRA-ADR 25419676. A 50-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration on 03Jun2021 (Lot Number: EW3143-L690) as single dose for COVID-19 immunisation. The patient medical history was not reported. Patient had not had symptoms associated with COVID-19. Patient was not enrolled in clinical trial. The patient''s concomitant medications were not reported. The patient experienced muscle pain on an unspecified date, pins and needles on an unspecified date, muscle ache on 03Jun2021. Started off with slight pins and needles in arm shortly after leaving vaccination center. After a few hours there was muscle pain at the injection site. This had remained during the following day. Patient had not tested positive for COVID-19 since having the vaccine. The events were reported as serious due to medically significant. The patient underwent lab tests and procedures which included COVID-19 virus test: Negative on 20May2021. The outcome of the event muscle ache and muscle pain at the injection site were not recovered, while the other events were recovering. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1415663 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-03
Onset:2021-06-03
   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: Nasopharyngitis, 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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021657801

Write-up: fever/cold and hot fever; cold and hot fever; Vomiting; This is a spontaneous report from a contactable consumer (patient) received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202106041325472710-VB615, Safety Report Unique Identifier GB-MHRA-ADR 25420531. A 32-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 03Jun2021 (Lot number was not reported) as 1st dose, single at the age of 32-year-old for COVID-19 immunisation. Medical history included lactation decreased. 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 currently breastfeeding. The patient''s concomitant medications were not reported. Patient had a couple of alcoholic drinks after receiving the vaccine, and have been vomiting all morning, with cold and hot fever on 03Jun2021. Patient has not tested positive for COVID-19 since having the vaccine. The seriousness was reported as medically significant. The outcome of event vomiting was recovering. The outcome of other event was unknown. No follow-up attempts are possible, information about batch number cannot be obtained.


VAERS ID: 1415677 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-03
Onset:2021-06-03
   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 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Feeling abnormal, Migraine with aura, Neck pain, Photophobia, SARS-CoV-2 test, Speech disorder, Visual impairment
SMQs:, Anticholinergic syndrome (broad), Dementia (broad), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (narrow), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Corneal disorders (broad), Retinal disorders (broad), Arthritis (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased; Multiple sclerosis; Suspected COVID-19 (Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Date: 20201212; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021657273

Write-up: light sensitivity; migraine aura; severe pain in neck; foggy head; unable to see or speak properly; unable to see or speak properly; This is a spontaneous report from a contactable consumer received from the Regulatory Authority Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202106041431426020-QPIYE, Safety Report Unique Identifier GB-MHRA-ADR 25421057. A 49-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 03Jun2021 (lot number: EW3143) as single dose for COVID-19 immunisation. Medical history included multiple sclerosis, lactation decreased, and suspected COVID-19 from 27Feb2020 (unsure when symptoms stopped). Multiple sclerosis but not medicated. She was not enrolled in clinical trial, not pregnant, and not currently breastfeeding. The patient''s concomitant medications were not reported. The patient experienced light sensitivity and migraine on 03Jun2021. Case narrative: About 45 mins after injection, she started to get migraine aura. She was unable to see or speak properly. Once the aura had faded, she had severe pain in neck. Twenty-four (24) hours later, she still had light sensitivity and foggy head. She has not tested positive for COVID-19 since having the vaccine. She underwent lab tests and procedures which included COVID-19 virus test: no - negative COVID-19 test on 12Dec2020. The patient was recovering from light sensitivity and migraine aura, while outcome of other events was unknown. Case was reported as medically significant by health authority. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1415735 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-31
Onset:2021-06-03
   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 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Dizziness, Headache, Malaise, SARS-CoV-2 test, Vision blurred
SMQs:, Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Glaucoma (broad), Lens disorders (broad), Retinal disorders (broad), Vestibular disorders (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210603; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021657309

Write-up: dizziness; blurred vision; weakness in arms and legs, general weakness; feeling and been sick; Headache; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202106041541367510-NKNR5. Safety Report Unique Identifier GB-MHRA-ADR 25421522. A 20-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 31May2021 as single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. He has not had symptoms associated with COVID-19 and not enrolled in clinical trial. The patient experienced dizziness and blurred vision on an unspecified date; headache on 03Jun2021. Case narrative: headache, weakness in arms and legs, blurred vision, feeling and been sick, general weakness, and dizziness, all lasting so random 15-minute period 4 days after the vaccine. No relevant investigations or tests conducted. He has not tested positive for COVID-19 since having the vaccine. He underwent lab tests and procedures which included COVID-19 virus test: no - negative COVID-19 test on 03Jun2021. The patient recovered from all events on 03Jun2021. Case was reported as medically significant by health authority. No follow-up attempts are possible; information about lot/batch number cannot be requested.


VAERS ID: 1415742 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-03
Onset:2021-06-03
   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 ELV3143 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain upper, Burning sensation, Diaphragmalgia, Dizziness, Eye pain, Eyelid sensory disorder, Facial pain, Malaise, Myalgia, Paraesthesia oral, SARS-CoV-2 test, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Periorbital and eyelid disorders (narrow), Hypotonic-hyporesponsive episode (broad), Tendinopathies and ligament 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: AMITRIPTYLINE; OMEPRAZOL; ZAPAIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anxiety; Clinical trial participant; Oesophageal acid reflux; Pain joint
Allergies:
Diagnostic Lab Data: Test Date: 20210527; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021657773

Write-up: immediately after having the vaccine; my eye first went numb; Eye sting; stomach started to feel tight; burning sensation; dizzy; Muscle ache; Feeling sick; Pain in diaphragm/ pain in the canter of my body below the ribs but above my stomach; Pain in face; my lip started to tingle; This is a spontaneous report from a contactable consumer (patient) received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202106041545567750-ODHI6 Safety Report Unique Identifier GB-MHRA-ADR 25421801. A 57-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 03Jun2021 (Lot Number: ELV3143) as single dose for COVID-19 immunization. Medical history included clinical trial, Study detail- (PRIVACY), anxiety, gastrooesophageal reflux disease, arthralgia. Patient has not had symptoms associated with COVID-19. Concomitant medications included amitriptyline taken for anxiety from 2020 to an unspecified stop date; omeprazole (OMEPRAZOL) taken for gastrooesophageal reflux disease from 2010 to an unspecified stop date; codeine phosphate, paracetamol (ZAPAIN) taken for arthralgia from 2010 to an unspecified stop date. The patient immediately after having the vaccine, my lip started to tingle I started to feel dizzy, after around 10 minutes a had a pain in the canter of my body below the ribs but above my stomach, then my stomach started to feel tight and it was strange to walk as I was not really aware of what was around me. later in the day I started to feel sick and developed a burning sensation in my stomach. The next day my eye first went numb and then started to sting. Patient also experienced fainting on unknown date, Muscle ache, pain in face on 03Jun2021. Outcome of event fainting, Burning sensation, dizzy was recovering, of Muscle ache, Pain in diaphragm, Pain in face was not recovered, of Feeling sick was recovered on unknown date, of others was unknown. Patient has not tested positive for COVID-19 since having the vaccine. The patient underwent lab tests and procedures which included sars-cov-2 test: no - negative covid-19 test on 27May2021. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1415745 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-03
Onset:2021-06-03
   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: Haemorrhage, Headache, Vaginal haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021657180

Write-up: Bled from vagina; Severe headache; Hemorrhage; This is a spontaneous report from a contactable consumer received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202106041552502330-IFEGP, and Safety Report Unique Identifier is GB-MHRA-ADR 25422051. A 35-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 03Jun2021 09:30 (lot/batch number was not reported) as 1st dose, single for COVID-19 immunisation. Medical history included lactation decreased. Patient has not had symptoms associated with COVID-19 and has not had a COVID-19 test. Patient is not enrolled in clinical trial. Patient is not pregnant and not currently breastfeeding. Concomitant medications were not reported. The patient experienced hemorrhage on 03Jun2021 with outcome of recovered on 03Jun2021, bled from vagina on 03Jun2021 22:30 with outcome of recovered on 03Jun2021 23:30, severe headache on 03Jun2021 13:00 with outcome of recovered on 04Jun2021. The events were assessed as serious (medically significant) by the regulatory authority. Additional Information: On 03Jun2021, patient had vaccine at 9.30 am. She had a severe headache around 1pm. Bled from vagina at approximately at 10.30pm. Bleeding stopped at around 11.30pm. On 04Jun2021, no blood and no other symptoms since period not due for at least 7 days and she was not pregnant. 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: 1415756 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-03
   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: Arthralgia, Headache, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased; Comments: Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test Patient is not enrolled in clinical trial Patient is not pregnant,Patient is not currently breastfeeding
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021657269

Write-up: Headache; Fever; Joint pain; This is a spontaneous report from a contactable consumer received from the Regulatory Authority (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202106041634145840-TFMB5, Safety Report Unique Identifier GB-MHRA-ADR 25422031. A 29-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on 02Jun2021 as 1st dose, single for COVID-19 immunization. Medical history included lactation decreased from an unknown date and unknown if ongoing. Patient has not had symptoms associated with COVID-19 and not had a COVID-19 test. Patient is not enrolled in clinical trial. Patient is not pregnant. Patient is not currently breastfeeding. The patient''s concomitant medications were not reported. The patient experienced headache, fever and joint pain on 03Jun2021. The reporter assessed all events as serious (medically significant). Patient has not tested positive for COVID-19 since having the vaccine. The outcome of the event headache was recovering while the outcome of the events fever and joint pain was recovered on 03Jun2021. No follow-up attempts are possible; information about batch/lot number cannot be obtained. No further information is expected.


VAERS ID: 1415765 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-03
   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: Fatigue, Nausea
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypothyroidism; Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021657952

Write-up: This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202106041729083630-5LEA9. Safety Report Unique Identifier is GB-MHRA-ADR 25422523.A 32-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration on 02Jun2021 (Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included hypothyroidism, Lactation decreased. Hypothyroidism, 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 nausea on 04Jun2021 with outcome of not recovered, tiredness on 03Jun2021 with outcome of not recovered.Additional Information: Patient has not tested positive for COVID-19 since having the vaccine. Case was reported as serious and seriousness criteria was medically significant. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1415780 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-03
   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 EW5143 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute chest syndrome, Blood pressure measurement, Dyspnoea, Electrocardiogram, Fatigue, Oxygen saturation, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (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: blood pressure; Result Unstructured Data: Test Result:Normal; Test Name: electrocardiogram; Result Unstructured Data: Test Result:Normal; Test Name: O2 levels; Result Unstructured Data: Test Result:Normal; Test Date: 20210604; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021657698

Write-up: struggling to breath deeply; fatigue; Acute chest syndrome; This is a spontaneous report from a contactable consumer received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202106041855010540-JGN0D, Safety Report Unique Identifier GB-MHRA-ADR 25423141. A 33-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 02Jun2021 (Lot Number: EW5143) as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. Patient has not had symptoms associated with COVID-19 Patient is not enrolled in clinical trial. The patient experienced Acute chest pain in the left side of the chest, right below the pectoral on 03Jun2021, struggling to breath deeply, it hurts a lot when the breath goes longer and deeper than a normal one, lack of air and fatigue on an unspecified date. The patient underwent lab tests and procedures which included blood pressure measurement: normal on an unspecified date, electrocardiogram: normal on an unspecified date, oxygen saturation: normal on an unspecified date, sars-cov-2 test: negative on 04Jun2021 No - Negative COVID-19 test. Outcome of event Acute chest syndrome was not recovered, of others was recovered on unknown date. Patient has not tested positive for COVID-19 since having the vaccine. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1415784 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-03
Onset:2021-06-03
   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: Chills, Fatigue, Headache, Myalgia, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (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: 5-HTP [OXITRIPTAN]; VITAMIN D 3; IBUPROFEN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anxiety; Lactation decreased; Suspected COVID-19
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021657925

Write-up: Headache; Chills; Fever; Fatigue; Muscle 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-202106041921375190-C18AM, Safety Report Unique Identifier GB-MHRA-ADR 25423410. A 32-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 03Jun2021 (Lot Number: EW3143) at single dose at the age of 32 years old for covid-19 immunisation. Medical history included suspected covid-19 from 31Mar2020 to 14Apr2020, lactation decreased from an unknown date, anxiety from an unknown date. No illnesses to report. Patient has not had a COVID-19 test. Patient is not enrolled in clinical trial. Concomitant medications included oxitriptan (5-HTP [OXITRIPTAN])(HEALTHSPAN) taken for anxiety from 20Apr2020 to an unspecified stop date; colecalciferol (VITAMIN D 3) ( oil capsules)taken for an unspecified indication from 01Sep2020 to an unspecified stop date; ibuprofen taken for an unspecified indication, start and stop date were not reported; thiamin, riboflavin, folic acid, vitamin b12, biotin, vitamin k, vitamin b6, calcium, vitamin a, pantothenic acid, vitamin d, vitamin e, zinc, iodine, vitamin c, niacin, iron, magnesium, manganese, copper (SAINSBURYS A-Z MULTIVITAMINS AND MINERALS TABLET) taken for an unspecified indication from 10Dec2020 to an unspecified stop date. The patient experienced fever on 03Jun2021, fatigue on 03Jun2021, muscle pain on 03Jun2021, headache on 04Jun2021, chills on 04Jun2021. The events were serious as medically significant. The clinical course was reported as follows: Al symptoms are currently being managed with a mixed strategy of paracetamol + ibuprofen. Patient has not tested positive for COVID-19 since having the vaccine. The outcome of the events fatigue, muscle pain was not recovered, of the other events was recovering. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1415785 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-03
Onset:2021-06-03
   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: SARS-CoV-2 test, Swelling face
SMQs:, Anaphylactic reaction (broad), Angioedema (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? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021657581

Write-up: Swelling face; This is a spontaneous report from a contactable physician. This is a report received from the Regulatory Agency (RA). Regulatory authority report number GB-MHRA-WEBCOVID-202106041922136470-6QNH4, Safety Report Unique Identifier GB-MHRA-ADR 25423365. A 36-year-old female patient received first dose of bnt162b2 (COVID-19 MRNA VACCINE BIONTECH, batch/lot number EW3143, expiration date not reported) via unspecified route of administration on 03Jun2021, at 36 years old as single dose for covid-19 immunization. The patient''s medical history was not reported. Patient has not had symptoms associated with COVID-19. Patient is not enrolled in clinical trial. Patient is not pregnant. The patient''s concomitant medications were not reported. The patient experienced swelling face on 03Jun2021. 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 unspecified date. The outcome of event was not resolved. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1415789 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-03
Onset:2021-06-03
   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: Chills, Fatigue, Limb discomfort, Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021657409

Write-up: Chills; Tiredness; Arm discomfort; Rash; This is a spontaneous report from a contactable consumer received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202106041943106740-4AG4E. Safety Report Unique Identifier GB-MHRA-ADR 25425773. A 31-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 03Jun2021 (Lot Number: ET8885) at the age of 31-years-old as single dose as COVID-19 vaccination. Medical history included suppressed lactation. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient was not enrolled in clinical trial. Patient was not pregnant, not pregnant at time of vaccination. Patient was not currently breastfeeding. The patient''s concomitant medications were not reported. The patient experienced chills on 04Jun2021, arm discomfort on 03Jun2021, rash on 03Jun2021, tiredness on 04Jun2021. This report was assessed as serious, medically significant. Outcome of the events was not recovered. 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: 1415797 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-03
Onset:2021-06-03
   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: Auditory disorder, Ear discomfort, Ear pain, Fatigue, Headache, Tinnitus, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hearing impairment (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: AMOXICILLIN; LORATADINE; GEDAREL; HYDROXOCOBALAMIN; SERTRALINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anemia B12 deficiency; Contraception; Depression; Hay fever; Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021657526

Write-up: felt like ears had popped ( like when on a plane ) the evening of vaccine; felt like ears had popped ( like when on a plane ) the evening of vaccine/Hives; Earache; Ringing in ears; Fatigue; Sounds are distorted.; Headache; This is a spontaneous report from a contactable other hcp received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202106042027548930-R2IUR. Safety Report Unique Identifier GB-MHRA-ADR 25423839. A 32-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration on 03Jun2021 (Lot Number: EW3143) as single dose for covid-19 immunisation. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient is not enrolled in clinical trial. Patient is not pregnant. Patient is not currently breastfeeding. Medical history included Lactation decreased, Hay fever, contraception, Anemia B12 deficiency, Depression, all from unknown date and unknown if ongoing. Concomitant medications included amoxicillin taken for an unspecified indication from 20Apr2021 to 27Apr2021; loratadine (NON-DROWSY HAYFEVER AND ALLERGY RELIEF) taken for Hay fever, start and stop date were not reported; desogestrel, ethinylestradiol (GEDAREL) taken for contraception, start and stop date were not reported; hydroxocobalamin taken for Anemia B12 deficiency, start and stop date were not reported; sertraline taken for depression, start and stop date were not reported. The patient experienced felt like ears had popped (like when on a plane) the evening of vaccine/Hives on an unspecified date, earache on 04Jun2021, ringing in ears on 04Jun2021, headache on 03Jun2021 and reported with the time between suspect drug administration and start of the event of 1 day, fatigue on 04Jun2021, all reported as serious due to medically significant. Felt like ears had popped (like when on a plane) the evening of vaccine, and then continued with ringing and heavy earache feeling still the day after. Sounds are distorted. The reporter did not think that the report related to possible blood clots or low platelet counts. Patient has not tested positive for COVID-19 since having the vaccine. The outcome of the event felt like ears had popped (like when on a plane) the evening of vaccine/Hives was recovering, of the event headache was recovered with sequelae, of the others was not recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1415817 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-03
   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: Blood test, Computerised tomogram, Magnetic resonance imaging, Pain in extremity, SARS-CoV-2 test, Seizure, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Clinical trial participant; COVID-19; Lactation decreased
Allergies:
Diagnostic Lab Data: Test Date: 20210604; Test Name: bloods; Result Unstructured Data: Test Result:found nothing; Test Date: 20210604; Test Name: CT scans; Result Unstructured Data: Test Result:found nothing; Test Date: 20210604; Test Name: MRI; Result Unstructured Data: Test Result:found nothing; Test Date: 20210604; Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC2021657492

Write-up: Seizures; fainted; felt terrible all of the 3rd june (day after vaccine) painful arm; This is a spontaneous report from a contactable consumer received from a regulatory authority. A 37-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW3143, expiry date not reported), via an unspecified route of administration on 02Jun2021 as first dose, single for covid-19 immunisation. Medical history included lactation decreased, clinical trial participant, had covid on an unspecified date. Patient has not had symptoms associated with COVID-19. Patient is not pregnant. Patient is not currently breastfeeding. The patient''s concomitant medications were not reported. The patient felt terrible all of the 03Jun2021 (day after vaccine) painful arm, similar feeling to when she had covid on an unspecified date. On 04Jun2021, patient went to the post office and fainted and had 2 seizures. Taken to hospital for tests - bloods, MRI and CT scans found nothing. Patient will not be having another vaccine. Tested negative for covid. The patient underwent lab tests and procedures which included COVID-19 virus test: negative (No - Negative COVID-19 test) on 04Jun2021. The patient recovered from seizures on 04Jun2021, while outcome of the remaining events was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1415821 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-03
Onset:2021-06-03
   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: Hypersensitivity, Lip swelling
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? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FEXOFENADINE; LEVOTHYROXINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergy; Hypothyroidism; Immunodeficiency (Has an illness or condition, not listed above, which reduces the immune response (e.g. immunodef...)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021657771

Write-up: lower lip started swelling; Allergy; This is a spontaneous report from a contactable consumer received from the Regulatory Authority (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202106042253016300-URDGP. Safety Report Unique Identifier GB-MHRA-ADR 25424744. A 36-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 03Jun2021 (at age of 36 years old) (Batch/Lot number was not reported) as single dose for COVID-19 immunization. Medical history included immunodeficiency (Has an illness or condition, not listed above, which reduces the immune response (e.g. immunodef), Allergy and Hypothyroidism. Concomitant medication(s) included fexofenadine taken for hypersensitivity from 16Feb2021 to an unspecified stop date; levothyroxine taken for hypothyroidism from 01Aug2016 to an unspecified stop date. The patient experienced allergy on 03Jun2021 with outcome of recovered on 03Jun2021, lower lip started swelling on an unspecified date with outcome of recovered. Clinical course as reported: My lower lip started swelling. I took Fexofenadine Anti-histamine tablets n recovered in 20mins, Patient has not tested positive for COVID-19 since having the vaccine. Patient has not had symptoms associated with COVID-19, Not had a COVID-19 test Patient is not enrolled in clinical trial. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1415835 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-03
   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: Musculoskeletal stiffness, Neck pain, SARS-CoV-2 test, Tenderness
SMQs:, Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Arthritis (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: High cholesterol; Ischaemic heart disease; Low sodium diet; Comments: None known. Known family issues but not present in myself include high cholesterol but healthy weights and diet on both sides of the family Father and his father had heart disease requiring stents. Patient has not had symptoms associated with COVID-19 Patient is not enrolled in clinical trial
Allergies:
Diagnostic Lab Data: Test Date: 20210603; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021657431

Write-up: arm tenderness; Difficulty turning head left and right; Stiff neck; Neck pain; This is a spontaneous report from a contactable consumer or other non -HCP. This is a report received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202106050653595100-Z8BLP. Safety Report Unique Identifier GB-MHRA-ADR 25425017 . A 32-year-old male patient received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration on 02Jun2021 (Batch/Lot Number: EW3143) as 1st dose, single for covid-19 immunisation. Medical history included blood cholesterol increased from an unknown date and unknown if ongoing, myocardial ischaemia from an unknown date and unknown if ongoing, medical diet from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. The patient experienced arm tenderness on an unspecified date with outcome of recovering, stiff neck on 03Jun2021 with outcome of not recovered, neck pain on 03Jun2021 with outcome of not recovered, difficulty turning head left and right on an unspecified date with outcome of unknown. Seriousness criteria of the events was medically significant. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 03Jun2021 No - Negative COVID-19 test. The clinical course was reported as follows: None known. Known family issues but not present in myself include high cholesterol but healthy weights and diet on both sides of the family Father and his father had heart disease requiring stents. Patient has not had symptoms associated with COVID-19. Felt fine immediately afterwards. Just some minor arm tenderness akin to a bruise. Following day neck pain and stiffness at rear and sides. Worse towards left side where injection took place. Minor first day and progressively worsened over next two days and ongoing. Difficulty turning head left and right. Down fine. Up mildly painful. 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: 1415848 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-03
   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, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20210108; Test Name: COVID-19 virus test; Test Result: Positive ; Comments: Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC2021657976

Write-up: Abdominal pain; This is a spontaneous report from a contactable consumer received from the regulatory authority (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202106050812260430-UG8VW Safety Report Unique Identifier GB-MHRA-ADR 25425149. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 02Jun2021 (Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included suspected covid-19 from 03Jan2021 to 14Jan2021. Patient is not enrolled in clinical trial. The patient''s concomitant medications were not reported. The patient experienced severe abdominal pain (disability) on 03Jun2021. The patient underwent lab tests and procedures which included COVID-19 virus test: positive (Yes - Positive COVID-19 test) on 08Jan2021. Outcome of the event was not recovered. No follow-up attempts are possible. Information about batch no cannot be obtained.


VAERS ID: 1415855 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-03
Onset:2021-06-03
   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: Malaise, Musculoskeletal stiffness, SARS-CoV-2 test
SMQs:, Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Arthritis (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Date: 20210604; Test Name: COVID-19 virus test; Test Result: Negative; Comments: Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021657403

Write-up: Sickness; Stiffness; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202106050922139490-LKBP3. Safety Report Unique Identifier GB-MHRA-ADR 25425331. A 34-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 03Jun2021 (at the age of 34 years) (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included lactation decreased Patient has not had symptoms associated with COVID-19. Patient is not enrolled in clinical trial. Patient is not pregnant, Patient is not currently breastfeeding. The patient''s concomitant medications were not reported. The patient experienced sickness and stiffness on 03Jun2021. The events were assessed a serious (medically significant). Lab data includes COVID-19 virus test: Negative COVID-19 test on 04Jun2021. Patient has not tested positive for COVID-19 since having the vaccine. The outcome of the event sickness was recovered on 04Jun2021 and stiffness was recovered on 05Jul2021. No follow-up attempts are possible, information about the batch number cannot be obtained.


VAERS ID: 1415856 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-03
   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: Fatigue, Migraine
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: GBPFIZER INC2021657396

Write-up: Migraine; Fatigue; This is a spontaneous report from a contactable consumer received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202106050931181990-YD44X, Safety Report Unique Identifier GB-MHRA-ADR 25425336. A 29-year-old female patient received BNT162B2, dose 1 via an unspecified route of administration on 02Jun2021 (Batch/Lot number: Unknown), as 1st dose, single for COVID-19 immunization. The patient medical history was not reported. No health concerns, 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 currently breastfeeding. The patient''s concomitant medications were not reported. On 03Jun2021, the patient experienced fatigue and on 04Jun2021 she experienced migraine. Patient has not tested positive for COVID-19 since having the vaccine. The case is serious (medically significant). The outcome of the event fatigue and migraine was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1415873 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-03
   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 ET8885 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Fatigue, Influenza, Migraine, Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Infective pneumonia (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: NAPROXEN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Migraine
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021657332

Write-up: Migraine; Vomiting; Flu symptoms; Tiredness; This is a spontaneous report from a contactable consumer received from a regulatory authority. A 31-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: ET8885), via an unspecified route of administration on 02Jun2021 as 1st dose, single for COVID-19 immunization. Medical history included migraine from an unknown date and unknown if ongoing. Patient has not had symptoms associated with COVID-19 and not had a COVID-19 test. Patient is not enrolled in clinical trial. Concomitant medications included naproxen taken for migraine, start and stop date were not reported. The patient experienced flu symptoms, tiredness on 03Jun2021, migraine and vomiting on 04Jun2021. The reporter assessed all events as serious (medically significant). Patient has not tested positive for COVID-19 since having the vaccine. The outcome of the events was not recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1415903 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-03
Onset:2021-06-03
   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: Headache, Injected limb mobility decreased, Limb discomfort, Malaise, Pain in extremity, Pyrexia, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021657412

Write-up: Painful arm; Arm was so sore and heavy patient could not move it upwards or out rendering her arm useless; patient could not move it upwards or out rendering her arm useless; Fever; headache; felt sick; This is a spontaneous report from a contactable consumer. The regulatory authority report number is GB-MHRA-WEBCOVID-202106051512078700-AHRCN. Safety Report Unique Identifier GB-MHRA-ADR 25425990. A 30-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 03Jun2021 (Batch/Lot Number: Not known) as single dose for COVID-19 vaccination. Medical history included suppressed lactation from an unknown date and unknown if ongoing. Patient has not had symptoms associated with COVID-19. Patient was not enrolled in clinical trial. Patient was not currently breastfeeding. The patient''s concomitant medications were not reported. The patient experienced painful arm on 03Jun2021 with outcome of recovering, fever on 03Jun2021 with outcome of recovered in Jun2021, headache on 03Jun2021 with outcome of recovered in Jun2021, felt sick on 03Jun2021 an unspecified date with outcome of recovered in Jun2021, all reported as disability. Clinical course reported as follow: Arm was so sore and heavy patient could not move it upwards or out rendering her arm useless. Fever, headache and felt sick. Paracetamol did help alleviate symptoms. Symptoms started 12 after jab and lasted about 12 hours. Patient has 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 an unspecified date. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1415919 (history)  
Form: Version 2.0  
Age: 23.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-03
Onset:2021-06-03
   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 V1185 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature abnormal, Eye pain, Fatigue, Headache, Injection site pain, Pain
SMQs:, Extravasation events (injections, infusions and implants) (broad), Glaucoma (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: BUSCOPAN; CODEINE; DULOXETINE; PARACETAMOL; TEGRETOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Depression; Irritable bowel syndrome; Nerve pain; Pain
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021657535

Write-up: Body temperature; Eye pain; Tiredness; Injection site pain; Headache; General body pain; This is a spontaneous report from a contactable consumer received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202106051714220030-BMSYI. Safety Report Unique Identifier GB-MHRA-ADR 25426201. A 23-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose at the age of 23-year-old via an unspecified route of administration on 03Jun2021 (Batch/lot number: ET888/V1185) as single dose for COVID-19 immunization. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient is not enrolled in clinical trial. Medical history included irritable bowel syndrome, pain from an unknown date and unknown if ongoing, depression, pain, Nerve pain, all from unknown date and unknown if ongoing. Concomitant medications included hyoscine butylbromide (BUSCOPAN) taken for irritable bowel syndrome, start and stop date were not reported; codeine taken for pain; duloxetine taken for depression; paracetamol taken for pain; carbamazepine (TEGRETOL) taken for neuralgia and all start and stop dates were not reported. The patient experienced headache on 03Jun2021, general body pain on 03Jun2021, body temperature on 04Jun2021, eye pain on 03Jun2021, tiredness on 03Jun2021, injection site pain on 03Jun2021 and all reported as serious due to medically significant with outcome of not recovered. Patient has not tested positive for COVID-19 since having the vaccine. The outcome of the event injection site pain was not recovered, of others was recovering. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1416023 (history)  
Form: Version 2.0  
Age: 23.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-03
Onset:2021-06-03
   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 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: METHYLPHENIDATE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthmatic; Attention deficit hyperactivity disorder; Lactation decreased
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC2021657961

Write-up: felt poorly (general brain fog); Painful arm; Sleep disturbance; This is a spontaneous report from a contactable Consumer(patient). This is a report received from the Regulatory Agency. Regulatory authority report number GB-MHRA-WEBCOVID-202106052102247390-53DPW, Safety Report Unique Identifier GB-MHRA-ADR 25426468. A 23-year-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration in arm on 03Jun2021 at her 23-year-old (Lot Number: Ew3143) as 1st dose, single for covid-19 immunisation. Medical history included suppressed lactation, asthmatic, attention deficit hyperactivity disorder. 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 methylphenidate taken for attention deficit hyperactivity disorder from 10May2021 to an unspecified stop date. The patient experienced painful arm on 03Jun2021 with outcome of recovering , sleep disturbance on 03Jun2021 with outcome of recovered, felt poorly (general brain fog) on an unspecified date with outcome of unknown. All events were assessed as medically significant. Lab data included COVID-19 virus test: negative on unknown date. The clinical course was reported as follows: Hours after jab arm was really painful. Couldn''t sleep on the side and couldn''t lift the arm at shoulder height for 2 days. First night of sleep was very disrupted and she felt poorly (general brain fog) and feeling under the weather. 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: 1416029 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-03
Onset:2021-06-03
   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: Burning sensation, Neck pain, Pain in extremity, Pain of skin, SARS-CoV-2 test
SMQs:, Peripheral neuropathy (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased; Raynaud''s
Allergies:
Diagnostic Lab Data: Test Date: 20210603; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Negative Results
CDC Split Type: GBPFIZER INC2021657929

Write-up: This is a spontaneous report from a contactable consumer received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202106052130019990-JM6GC, Safety Report Unique Identifier GB-MHRA-ADR 25426494. A 35-year-old female patient received BNT162B2 (COVID-19 MRNA VACCINE BIONTECH), dose 1 via an unspecified route of administration at single dose on 03Jun2021 at age of 35-year-old for covid-19 immunisation. Medical history included Lactation decreased, Raynauds. 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 Painful arm, arm and neck pain for 2 days after the vaccine on 03Jun2021 with outcome of recovered on 05Jun2021, scalp tenderness, burning on 05Jun2021 with outcome of not recovered. The patient underwent lab tests and procedures which included COVID-19 virus test: negative results on 03Jun2021. Clinical course: Arm and neck pain for 2 days after the vaccine, 3rd day scal tenderness and burning that would not go away. Patient has not tested positive for COVID-19 since having the vaccine Suspect Reactions. No details of any relevant investigations or tests conducted provided. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1416048 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-03
Onset:2021-06-03
   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: Anaphylactic reaction, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypersensitivity (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: EPIPEN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Peanut allergy
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021657235

Write-up: Anaphylaxis; This is a spontaneous report from a contactable healthcare professional received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202106060111378330-9YQCV. Safety Report Unique Identifier is GB-MHRA-ADR 25426658. A 32-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 03Jun2021 (lot number: EW3143) as single dose for COVID-19 immunisation. Medical history included peanut allergy. He has not had symptoms associated with COVID-19 and not enrolled in clinical trial. Concomitant medication included epinephrine (EPIPEN). The patient experienced anaphylaxis on 03Jun2021 with outcome of recovered on 03Jun2021. Case narrative: The patient reported feelings of anaphylaxis similar to when he had peanut allergy. Epipen discharged. He was monitored and taken to a hospital. He underwent lab tests and procedures which included COVID-19 virus test: no - negative COVID-19 test on an unknown date. Case was reported as non-serious by health authority. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1416053 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-03
   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: Cough, Lacrimation increased, Lymphadenopathy, Nasopharyngitis, Oropharyngeal pain, Rhinorrhoea
SMQs:, Anaphylactic reaction (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Lacrimal disorders (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021657224

Write-up: runny nose; watery eye; Common cold; chesty cough/Cough; Sore throat; raised glands; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202106060516094650-EGX5M. Safety Report Unique Identifier GB-MHRA-ADR 25426696. A 34-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 02Jun2021 (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included lactation decreased. It was reported that the patient is usually very fit and well. 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. It was reported that the day after the jab (03Jun2021), the patient developed a sore throat with raised glands. The day after that (04Jun2021, also reported as "03Jun2021"), she had an all-out cold. The patient also experienced chesty cough on 04Jun2021, runny nose and watery eyes on an unspecified date. The events were assessed as serious (medically significant). Patient has not tested positive for COVID-19 since having the vaccine. The outcome of the events cold and sore throat was not recovered; while unknown for the rest of the events. No follow-up attempts are possible, information about the batch number cannot be obtained.


VAERS ID: 1416118 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-03
Onset:2021-06-03
   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 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC2021657337

Write-up: Headache; Nausea; Dizziness; The patient received the first dose of BNT162B2 on 26Feb2021 and the second dose on 03Jun2021; This is a non-interventional study report from a contactable consumer received from the regulatory authority. The regulatory authority report number is GB-MHRA-YCVM-202106041001148320-ZQQ37, Safety Report Unique Identifier GB-MHRA-ADR 25419086. A 49-years-old female patient received the second single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, on 03Jun2021 (Lot Number: EW3143), at the age of 49 years, for COVID-19 immunisation. Medical history included type 2 diabetic. The first dose of BNT162B2 vaccine was administered on 26Feb2021 (Batch/lot number: EL8713). Unsure if patient has had symptoms associated with COVID-19. Patient was not enrolled in clinical trial, was not pregnant and was not currently breastfeeding. The patient''s concomitant medications were not reported. The patient experienced headache on 04Jun2021 with outcome of not recovered, nausea on 03Jun2021 with outcome of not recovered, dizziness on 03Jun2021 with outcome of not recovered. The events were reported as serious as medically significant. The patient underwent lab tests and procedures which included COVID-19 virus test: negative on unspecified date. Additional information included: Type 2 diabetic. The reporter''s assessment of the causal relationship of the events headache, nausea and dizziness 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 current available information and the plausible drug-event temporal association, there is a reasonable possibility that events Headache, Nausea, and Dizziness were related to suspect drug.


VAERS ID: 1416212 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-03
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002917 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Pyrexia, Urine output, Urine output decreased
SMQs:, Acute renal failure (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Chronic kidney disease (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210603; Test Name: Urinary output; Result Unstructured Data: Urinary output diminished
CDC Split Type: ITMODERNATX, INC.MOD20212

Write-up: urinary output diminished; This regulatory authority case was reported by a pharmacist and describes the occurrence of PYREXIA and URINE OUTPUT DECREASED (urinary output diminished) in a 60-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3002917) for COVID-19 vaccination. No Medical History information was reported. On 01-Jun-2021, the patient received dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) .5 milliliter in total. On 03-Jun-2021, the patient experienced PYREXIA (seriousness criterion hospitalization) and URINE OUTPUT DECREASED (urinary output diminished) (seriousness criterion hospitalization). The patient was hospitalized on 03-Jun-2021 due to PYREXIA and URINE OUTPUT DECREASED. At the time of the report, PYREXIA and URINE OUTPUT DECREASED (urinary output diminished) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Jun-2021, Urine output: urinary output diminished (Low) Urinary output diminished. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) was unknown. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medication were not provided.Treatment information was not provided. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.


VAERS ID: 1416256 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-03
Onset:2021-06-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY0779 / 2 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021663137

Write-up: Itching on both forearms; Skin eruption on both forearms; This is a spontaneous report from a contactable physician received via COVID-19 Vaccine Adverse Event Self-Reporting Solution (COVAES). The patient was a 27-year-old male. The most recent COVID-19 vaccine was administered in hospital. The patient didn''t receive any other vaccines within 4 weeks prior to the COVID vaccine. There was no other medical history. The patient had no allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. On 13May2021 at 02:30PM, the patient previously received the first single dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number EW4811, Expiration date 31Jul2021) intramuscular at left arm for COVID-19 immunization. On 03Jun2021 at 03:00PM (the day of vaccination), the patient received the second single dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number: EY0779, Expiration Date: 31Aug2021) intramuscular at left arm for COVID-19 immunization. On 03Jun2021 at 03:30PM (30 minutes after the vaccination), the patient experienced Itching and Skin eruption on both forearms. The outcome of the event was recovered with treatment including injection of Solu-Medrol 125, Gaster 20, NEORESTAR 10, Sodium Chloride 50ml. Since the vaccination, the patient hasn''t been tested for COVID-19. The reporter started the events result in professional office or clinic visit.; Sender''s Comments: Based on temporal association, the causal relationship between BNT162B2 and the events pruritus and rash cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once 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: 1416614 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-03
Onset:2021-06-03
   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: Chills, Decreased appetite, Fatigue, Insomnia, Myalgia, Nausea, Pain in extremity, SARS-CoV-2 test, Testicular pain
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), 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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Glandular fever; Suspected COVID-19 (Unsure when symptoms stopped); Comments: Glandular fever 2007 Patient is not enrolled in clinical trial
Allergies:
Diagnostic Lab Data: Test Date: 20201223; Test Name: COVID-19 virus test; Test Result: Positive ; Result Unstructured Data: positive
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: aches back of legs; Aches & pains in legs; Testicular pain; Fatigue; Nausea; Decreased appetite; Insomnia; Chills; This regulatory authority case was reported by a consumer and describes the occurrence of MYALGIA (aches back of legs), CHILLS (Chills), PAIN IN EXTREMITY (Aches & pains in legs), TESTICULAR PAIN (Testicular pain), FATIGUE (Fatigue), NAUSEA (Nausea), DECREASED APPETITE (Decreased appetite) and INSOMNIA (Insomnia) in a 35-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3002332) for COVID-19 vaccination. Glandular fever 2007 Patient is not enrolled in clinical trial. The patient''s past medical history included Glandular fever and Suspected COVID-19 (Unsure when symptoms stopped) on 21-Dec-2020. On 03-Jun-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 03-Jun-2021, the patient experienced CHILLS (Chills) (seriousness criterion medically significant), FATIGUE (Fatigue) (seriousness criterion medically significant), NAUSEA (Nausea) (seriousness criterion medically significant), DECREASED APPETITE (Decreased appetite) (seriousness criterion medically significant) and INSOMNIA (Insomnia) (seriousness criterion medically significant). On 04-Jun-2021, the patient experienced PAIN IN EXTREMITY (Aches & pains in legs) (seriousness criterion medically significant) and TESTICULAR PAIN (Testicular pain) (seriousness criterion medically significant). On an unknown date, the patient experienced MYALGIA (aches back of legs) (seriousness criterion medically significant). On 04-Jun-2021, NAUSEA (Nausea) and INSOMNIA (Insomnia) had resolved. On 05-Jun-2021, CHILLS (Chills) and DECREASED APPETITE (Decreased appetite) had resolved. On 06-Jun-2021, PAIN IN EXTREMITY (Aches & pains in legs) and TESTICULAR PAIN (Testicular pain) had resolved. On 07-Jun-2021, MYALGIA (aches back of legs) and FATIGUE (Fatigue) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Dec-2020, SARS-CoV-2 test: positive positive (Positive) positive. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant medication was provided by the reporter. No treatment medication was provided by the reporter. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. 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: 1416657 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-06-03
Onset:2021-06-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Confusional state, Fatigue, Lymphadenopathy, Myalgia, Nausea, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210610; 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: Swollen lymph nodes; Muscle pain; Fatigue; Nausea; Confusion; This regulatory authority case was reported by a consumer and describes the occurrence of CONFUSIONAL STATE (Confusion), LYMPHADENOPATHY (Swollen lymph nodes), MYALGIA (Muscle pain), FATIGUE (Fatigue) and NAUSEA (Nausea) in a 30-year-old patient of an unknown gender who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 03-Jun-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 03-Jun-2021, the patient experienced CONFUSIONAL STATE (Confusion) (seriousness criterion medically significant), MYALGIA (Muscle pain) (seriousness criterion medically significant), FATIGUE (Fatigue) (seriousness criterion medically significant) and NAUSEA (Nausea) (seriousness criterion medically significant). On 04-Jun-2021, the patient experienced LYMPHADENOPATHY (Swollen lymph nodes) (seriousness criterion medically significant). On 05-Jun-2021, MYALGIA (Muscle pain) had resolved. At the time of the report, CONFUSIONAL STATE (Confusion) and LYMPHADENOPATHY (Swollen lymph nodes) was resolving, FATIGUE (Fatigue) had not resolved and NAUSEA (Nausea) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Jun-2021, SARS-CoV-2 test: no - negative covid-19 test (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant medication was reported. No treatment medication was reported. Patient has 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: 1417489 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-06-03
Submitted: 0000-00-00
Entered: 2021-06-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Diverticulitis, Pain in extremity, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific inflammation (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? 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: BEPFIZER INC2021664518

Write-up: pain at arm during 1 or 2 days after 1st injection; Fever the day after vaccination; Intestinal diverticulitis before second dose; This is a spontaneous report from a contactable consumer (patient). A 78-year-old female patient received bnt162b2 (COMIRNATY), first single dose via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) for covid-19 immunisation. The patient medical history and concomitant drugs were not reported. The patient was scheduled for the second dose of vaccine on 04Jun2021 but on the morning of 03Jun2021, she experienced fever and difficult defecation which was diagnosed by the doctor as intestinal diverticulitis. The patient also experienced pain at arm during 1 or 2 days after 1st injection and fever the day after vaccination on unspecified dates. Therapeutic measures (antibiotics) were taken as result of intestinal diverticulitis before second dose (diverticulitis) but the molecules were not specified. Outcome of the event intestinal diverticulitis was unknown, while outcome of the other events was recovered. Information on the lot/batch number has been requested.


VAERS ID: 1417497 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-03
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 RA / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Body temperature, Chest pain, Chills, Cough, Decreased appetite, Eye pain, Headache, Pain, Pain in extremity, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Glaucoma (broad), Cardiomyopathy (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? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NITROFURANTOIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Kidney stone
Allergies:
Diagnostic Lab Data: Test Date: 20210603; Test Name: fever; Result Unstructured Data: Test Result:37 to 39 Centigrade; Comments: at 20:00
CDC Split Type: BRPFIZER INC2021663416

Write-up: Fever between 37 to 39 degrees; headache; pain in eyes; body pain; chills; body strengthless; no appetite; pain in arm; cough; chest pain; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient received first dose of BNT162B2 (COMIRNATY), via an unspecified route of administration, administered in right arm on 02Jun2021 09:00 (at the age of 46-year-old) as single dose for covid-19 immunisation. Medical history included kidney stone. Concomitant medications included influenza A(H1N1) pdm09 vaccine taken for H1N1 influenza immunisation on 15May2021 and nitrofurantoin. On 03Jun2021 at 20:00, the patient experienced fever between 37 to 39 degrees, headache, pain in eyes, body pain, chills, body strengthless, no appetite, pain in arm, cough, chest pain. Seriousness Criteria for events was disability or permanent damage. No treatment was received for the adverse events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient was not pregnant. The outcome of the events was not recovered. Information on the lot/batch number has been requested.


VAERS ID: 1418258 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-06-03
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: Blood test, Computerised tomogram, Dizziness, Headache, Myalgia, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Vestibular disorders (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, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Neuropathy (Cause of neuropathy unknown); Whiplash injury (Chronic whiplash)
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data: Test Date: 202106; Test Name: CT scan; Result Unstructured Data: Normal; Test Date: 202106; Test Name: Blood test; Result Unstructured Data: Normal
CDC Split Type: DKJNJFOC20210637605

Write-up: DIZZINESS WITH A SWAYING FEELING; LOW FEVER; MUSCLE PAIN; HEADACHE; This spontaneous report received from a consumer via a Regulatory Authority [EMEA EVHUMAN NLP, DK-DKMA-WBS-0070952] concerned a 36 year old female of unknown race and ethnic origin. The patient''s weight was 49 kilograms, and height was 172 centimeters. The patient''s concurrent conditions included whiplash injury, and neuropathy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: XD975 and expiry: UNKNOWN) 1 dosage forms, 1 total, administered on 03-JUN-2021 for covid-19 immunisation. No concomitant medications were reported. On an unspecified date in JUN-2021, Laboratory data included: Blood test Normal, and Computerised tomogram Normal. On 03-JUN-2021, the patient experienced dizziness with a swaying feeling, low fever, muscle pain, and headache, and was hospitalized (date unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from low fever, muscle pain, headache, and dizziness with a swaying feeling. This report was serious (Hospitalization Caused / Prolonged).; Sender''s Comments: 20210637605-covid-19 vaccine ad26.cov2.s-dizziness with a swaying feeling. 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). 20210637605-covid-19 vaccine ad26.cov2.s-low fever, muscle pain, headache. This event(s) is labeled and is therefore considered potentially related.


VAERS ID: 1418742 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-03
Onset:2021-06-03
   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 - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Headache, Nausea, SARS-CoV-2 test, Vision blurred, Vomiting
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Lens 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: FEXOFENADINE; RIGEVIDON [ETHINYLESTRADIOL;LEVONORGESTREL]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Multiple allergies
Allergies:
Diagnostic Lab Data: Test Date: 20210604; Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC2021671637

Write-up: nausea; Vomiting; Headache; Blurred vision; This is a spontaneous report from a contactable consumer received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202106041931044710-8IILT, Safety Report Unique Identifier GB-MHRA-ADR 25423438. A 28-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 03Jun2021 as dose1, single for COVID-19 immunisation, at the age of 28-years-old. Medical history included multiple allergies. Patient had not had symptoms associated with COVID-19 and was not enrolled in clinical trial. Patient was not pregnant and was not currently breastfeeding. Concomitant medications included fexofenadine taken for multiple allergies from 09Aug2020 to an unspecified stop date; ethinylestradiol, levonorgestrel (RIGEVIDON) taken for an unspecified indication from 11Oct2019 to an unspecified stop date. The patient experienced nausea on 04Jun2021, vomiting, headache and blurred vision on 03Jun2021. The events were reported as serious as important medical events. It was reported that patient started with headache within half an hour, 5 hours later severe headache, blurred vision, vomiting. By morning after slight nausea and headache. The patient underwent lab tests and procedures which included COVID-19 virus test: negative on 04Jun2021. The patient was recovering from nausea and headache, had recovered from vomiting on 03Jun2021 and from blurred vision on 04Jun2021. No follow-up attempts are possible. Information about batch/lot number cannot be obtained.


VAERS ID: 1422651 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-03
Onset:2021-06-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA2453 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Dyspnoea, Headache, Hyperventilation, Hypoaesthesia, Tachypnoea, Tension
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Peripheral neuropathy (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Respiratory failure (broad), Infective pneumonia (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: 20210603; Test Name: body temperature; Result Unstructured Data: Test Result:36.9 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC2021672529

Write-up: Headache; Dyspnoea; Numbness of limbs; Tachypnea; Hyperventilation syndrome; mental tension; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21112221. The patient was an 18-year and 8-month-old female. Body temperature before vaccination was 36.9 degrees Centigrade (on 03Jun2021). The patient had no medical history. On 03Jun2021 at 15:00 (the day of vaccination) (18-year-old at vaccination), the patient received the first dose of BNT162B2 (COMIRNATY, solution for injection, lot number FA2453, expiration date 31Aug2021) via an unspecified route of administration as a single dose for COVID-19 immunization. Concomitant medications were not reported. On 03Jun2021 at 15:08 (8 minutes after the vaccination), the patient experienced headache, dyspnoea, and numbness of limbs. On 03Jun2021 (the same day of the vaccination), the outcome of the event was recovered. The course of the event was as follows: About eight minutes after the vaccination, the patient experienced headache, dyspnoea, and numbness of limbs. Oxygen administration, adrenaline 0.3mg intramuscular, securing vascular access was carried out. The patient was experiencing tachypnea. Auscultation was performed but no wheeze was observed. With the Breathing rate became normal, headache and numbness of limbs disappeared. About two hours later, symptoms totally disappeared. There was absolutely no blood pressure low and oxygen saturation low during observation. The reporting physician classified the event as non-serious 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 Hyperventilation syndrome. The reporting physician commented as follows: Judged by symptoms happened during observation, the physician guessed that hyperventilation syndrome was caused by mental tension. The physician thought that no anaphylaxis, no adrenaline administration was needed (as reported). The outcome of all events was resolved on 03Jun2021 at 17:08.


VAERS ID: 1424956 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-03
Onset:2021-06-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC1526 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Feeling hot, Hyperhidrosis, Syncope, Tremor
SMQs:, Torsade de pointes/QT prolongation (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergic bronchospasm; Allergic rhinoconjunctivitis; Food allergy
Allergies:
Diagnostic Lab Data: Test Date: 20210603; Test Name: Blood pressure; Result Unstructured Data: Test Result:80/60 mmHg
CDC Split Type: ITPFIZER INC2021674442

Write-up: After a few minutes from the administration of the vaccine, profuse sweating, syncope, tremors in the limbs. Spontaneous recovery. Patient reports feeling of heat.; After a few minutes from the administration of the vaccine, profuse sweating, syncope, tremors in the limbs. Spontaneous recovery. patient reports feeling of heat.; After a few minutes from the administration of the vaccine, profuse sweating, syncope, tremors in the limbs. Spontaneous recovery. Patient reports feeling of heat.; After a few minutes from the administration of the vaccine, profuse sweating, syncope, tremors in the limbs. Spontaneous recovery. Patient reports feeling of heat.; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number IT-MINISAL02-739547. A 17-year-old male patient received bnt162b2 (COMIRNATY), dose 1 intramuscular, administered in Arm Left (reported as left shoulder) on 03Jun2021 (Lot Number: FC1526; Expiration Date: 30Sep2021) as 0.3 ML SINGLE (at the age of 17-years-old) for COVID-19 immunization. Medical history included Allergic bronchospasm and Allergic rhinoconjunctivitis both from an unknown date and unknown if ongoing, and food allergy. There were no concomitant medications. The patient experienced after a few minutes from the administration of the vaccine, profuse sweating, syncope, tremors in the limbs. Spontaneous recovery. Patient reports feeling of heat, all on 03Jun2021. The patient was hospitalized for the events. Actions taken (Administration of intravenosus= i.v. physiological solution). The patient underwent lab tests and procedures which included blood pressure measurement: 80/60 mmHg on 03Jun2021. The outcome of the events was recovered on 04Jun2021. Reporter comment: Blood pressure= PA detected 80/60 mmHg. Polyallergic patient to inhalants (rhinoconjunctivitis and episodic bronchospasm). Previous food allergy. No known drug allergies. No concomitant medication intake. No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: PA detected 80/60 mmHg. Polyallergic patient to inhalants (rhinoconjunctivitis and episodic bronchospasm). Previous food allergy. No known drug allergies. No concomitant medication intake.


VAERS ID: 1438593 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-03
Onset:2021-06-03
   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 - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Headache, Malaise, Maternal exposure during breast feeding, Maternal exposure during pregnancy, Migraine, Off label use, Product use issue, SARS-CoV-2 test, Vision blurred
SMQs:, Anticholinergic syndrome (broad), Glaucoma (broad), Lens disorders (broad), Retinal disorders (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Neonatal exposures via breast milk (narrow), Medication errors (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PARACETAMOL
Current Illness: Breast feeding
Preexisting Conditions: Medical History/Concurrent Conditions: Pain relief; Pregnancy (Patient no longer pregnant at the time of reporting.)
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 INC2021710064

Write-up: blurred vision; feeling or being sick; Maternal exposure during breast feeding; Maternal exposure during breast feeding; Maternal exposure during breast feeding; Headache; Migraine; Maternal exposure during pregnancy; This is a spontaneous report from a contactable consumer received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202106141146254060-KCJ5X, Safety Report Unique Identifier: GB-MHRA-ADR 25469510. This is maternal report. A 34-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 03Jun2021 (lot number: not known) at dose 1, single for COVID-19 immunisation. Medical history included pregnancy (patient no longer pregnant at the time of reporting), ongoing breast feeding, and pain relief. Unsure if patient has had symptoms associated with COVID-19. Patient is not enrolled in clinical trial. Concomitant medication included paracetamol taken for pain relief from 03Jun2021. The patient experienced maternal exposure during pregnancy (on 03Jun2021), maternal exposure during breast feeding on an unspecified date; and headache and migraine on 04Jun2021. Clinical course reported: constant headache from last 10 days after getting vaccine. A severe headache that was not relieved with painkillers or was getting worse and felt worse when lie down or bend over a headache, that''s unusual and occurred with blurred vision, feeling or being sick. The medicine did not have an adverse effect on any aspect of the pregnancy. Relevant investigations or tests conducted: "NA". Patient has 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 events headache and migraine was not recovered; and for other events was unknown. Regulatory authority assessed the events as serious: disability and medically significant. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1448794 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-03
Onset:2021-06-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW2245 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Maternal exposure during pregnancy, Pain in extremity, SARS-CoV-2 test, Scan
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: 14Oct2021.)
Preexisting Conditions: Medical History/Concurrent Conditions: Folic acid supplementation
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:Normal
CDC Split Type: GBPFIZER INC2021736326

Write-up: Hand pain; Maternal exposure during pregnancy; This is a solicited report from a regulatory authority from a contactable consumer. This is a report from received from a regulatory authority (RA). The regulatory authority report number is GB-MHRA-YCVM-202106031438033550-DC2QL, Safety Report Unique Identifier GB-MHRA-ADR 25494183. A 33-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 03Jun2021 (Lot Number: EW2245) at the age of 33-year-old as single dose for COVID-19 vaccination. Medical history included ongoing pregnancy (estimated due date: 14Oct2021), and folic acid supplementation. Patient was exposed to the vaccine second-trimester (13-28 weeks). Patient had not had symptoms associated with COVID-19. Patient was not enrolled in clinical trial. Patient was not currently breastfeeding. 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 03Jun2021 with outcome of unknown, hand pain on 04Jun2021 with outcome of recovered on 05Jun2021. The event hand pain was reported as serious (medically significant). Patient did not think vaccination had an adverse effect on any aspect of the pregnancy. The patient underwent lab tests and procedures on an unspecified date which included covid-19 virus test: no - negative covid-19 test; scans: normal. Patient had not tested positive for COVID-19 since having the vaccine. The reporter''s assessment of the causal relationship of the hand pain with the bnt162b2 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: A causal association between BNT162B2 and the reported events cannot be excluded based on temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.


VAERS ID: 1496207 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-03
Onset:2021-06-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET8885 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Maternal exposure during breast feeding, Maternal exposure during pregnancy, Off label use, Product use issue, Threatened labour
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Neonatal exposures via breast milk (narrow), Medication errors (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: ENOXAPARIN; FOLIC ACID; LEVOTHYROXINE; METFORMIN
Current Illness: Breast feeding; Pregnancy
Preexisting Conditions: Medical History/Concurrent Conditions: Deep vein thrombosis; Folic acid supplementation; Hypothyroidism; Polycystic ovaries; Pregnancy (First pregnancy through IVF with donor sperm); Suspected COVID-19
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021863691

Write-up: Threatened premature labor; Maternal exposure during pregnancy; Maternal exposure during breast feeding; maternal exposure during breast feeding; maternal exposure during breast feeding; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202107061633449950-2LEYR,Safety Report Unique Identifier GB-MHRA-ADR 25605360. This consumer reported information for both mother and baby. This is a maternal report. A 30-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration at the age of 30-year-old on 03Jun2021 (Lot Number: ET8885) as single dose for COVID-19 immunisation. Medical history included ongoing pregnancy, ongoing breast feeding, suspected covid-19 from 02Mar2020 to 20Mar2020, deep vein thrombosis, Folic acid supplementation, hypothyroidism, polycystic ovaries, pregnancy (First pregnancy through IVF with donor sperm). Not had a COVID-19 test Patient is not enrolled in clinical trial. Concomitant medications included enoxaparin taken for deep vein thrombosis from 01May2021 to an unspecified stop date; folic acid taken for Folic acid supplementation, start and stop date were not reported; levothyroxine taken for hypothyroidism, start and stop date were not reported; metformin taken for polycystic ovaries, start and stop date were not reported. The patient experienced maternal exposure during pregnancy (hospitalization, disability, medically significant) on 03Jun2021, maternal exposure during breast feeding (hospitalization, disability, medically significant) on 03Jun2021, threatened premature labor (hospitalization, disability, medically significant) on 06Jun2021. The outcome of event threatened premature labor was recovering. The outcome of other events was unknown. The clinical course was reported as follows: On Sunday 06Jun2021 (3 days after patient had the vaccine), patient''s waters broke prematurely at 30 weeks 2 days pregnant. This is also known as PPROM (preterm prelabour rupture of membranes). PPROM has not resulted in premature labour so far - patient was now 34 weeks and 4 days pregnant. Patient had no evidence to suggest this was a direct result of the vaccine but felt compelled to report it incase there is a pattern and other women have experienced similar. Patient has not tested positive for COVID-19 since having the vaccine. Details of previous pregnancies: First pregnancy through IVF with donor sperm. Patient was exposed to the medicine Third-trimester (29-40 weeks). No follow up attempts are possible. No further information is expected.


VAERS ID: 1496245 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-19
Onset:2021-06-03
   Days after vaccination:15
Submitted: 0000-00-00
Entered: 2021-07-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Inappropriate schedule of product administration, Lymphadenopathy, Maternal exposure timing unspecified, SARS-CoV-2 test, Scan, Tremor, Vitamin D decreased
SMQs:, Neuroleptic malignant syndrome (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Pregnancy
Allergies:
Diagnostic Lab Data: Test Name: blood test; Result Unstructured Data: Test Result:low Vitamin D; Test Name: COVID-19 virus test; Test Result: Negative ; Test Name: SPECT Scan; Result Unstructured Data: Test Result:nothing to indicate another explanation; Comments: nothing to indicate another explanation for the enlargement of the lymph nodes, other than the vaccine
CDC Split Type: GBPFIZER INC2021864057

Write-up: low vitamin; an exposure during pregnancy; dose 1 on 19May2021, dose 2 on 03Jul2021; Shaking; Enlarged lymph nodes (excl infective); This is a spontaneous report from a contactable consumer or other non hcp received from a regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202107062041167410-GPEG1. Safety report unique identifier GB-MHRA-ADR 25607200. A 37-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 19May2021 (Batch/Lot number was not reported) as single dose, dose 2 via an unspecified route of administration on 03Jul2021 (Batch/Lot number was not reported) as single dose, for COVID-19 immunization. Patient has not had symptoms associated with COVID-19. Patient is not enrolled in clinical trial. Medical history included pregnancy from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. The patient experienced low vitamin on an unspecified date with outcome of recovering, enlarged lymph nodes (excl infective) on 03Jun2021 with outcome of not recovered, shaking on 06Jul2021 with outcome of not recovered. About a week or so after the 1st dose, the patient noticed a lymph node under left armpit was enlarged. After another week or so as the left armpit enlarged node reduced in size, a new one developed on the right. They alternated between left and right armpit till about 4 weeks after 1st dose. The patient had just had a SPECT Scan about 3 months prior and there was nothing to indicate another explanation for the enlargement of the lymph nodes, other than the vaccine. The patient also had a blood test about 3 weeks after the 1st dose and nothing except low Vitamin D. The patient just had the 2nd dose and nodes on the left are enlarging now. The patient also experienced and was still experiencing shaking after the vaccine, most especially arms and hands. The shaking lasted over a week after the 1st dose and its been 2 days now with the 2nd dose. No medication was taken for any of these reactions. Adverse reaction did not occur as a result of an exposure during pregnancy. The patient underwent lab tests and procedures which included COVID-19 virus test on an unspecified date: No - Negative COVID-19 test. 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: 1366589 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Indiana  
Vaccinated:2021-06-01
Onset:2021-06-02
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 RA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Chills, Feeling cold, Feeling hot, Headache, Nausea, Pain, Tremor
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (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? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Prenatal vitamin, Tylenol
Current Illness: Sinus infection few weeks ago
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data:
CDC Split Type:

Write-up: Cold chills , then warm , shaking , achy , some nausea and headache


VAERS ID: 1366597 (history)  
Form: Version 2.0  
Age: 63.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-04-29
Onset:2021-06-02
   Days after vaccination:34
Submitted: 0000-00-00
Entered: 2021-06-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 036B21A / UNK LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Ageusia, Anosmia, Arthralgia, Blood test, Dry eye, Dry mouth, Dry skin, Fatigue, Immune system disorder, Myalgia, Urine analysis
SMQs:, Rhabdomyolysis/myopathy (broad), Taste and smell disorders (narrow), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Corneal disorders (broad), Eosinophilic pneumonia (broad), Conjunctival disorders (narrow), Lacrimal disorders (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad), Dehydration (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: Atenolol, Synthroid, Atorvastatin, Sertraline, Duloxetine, Buspar, Oxybutynin, Fentanyl patch
Current Illness: None
Preexisting Conditions: Degenerative disc disease, osteoarthritis, chronic pain,
Allergies: Lactose intolerant
Diagnostic Lab Data: Blood tests, urine sample
CDC Split Type:

Write-up: No taste, no smell, fatigue, dry eyes, no saliva, extra dry skin, sore joints and muscles. Immune system attacking


VAERS ID: 1366856 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-06-02
Onset:2021-06-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 033C21A / 2 LA / IM

Administered by: Military       Purchased by: ?
Symptoms: Full blood count, 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? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: Hives after IM flu vaccine. PT stated it happened over a decade ago
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Provider ordered a CBC
CDC Split Type:

Write-up: PT reported to the Clinic around 1500. PT stated she received the second dose of the Moderna Vaccine around 1330. PT stated she started to break out in pin point hives on both arms around 1450. PT stated she has had hives after a flu vaccine before. PT states it was over a decade ago. PT denies any difficulty breathing or any other symptoms. I called the on call provider and the PT was seen in clinic at 1536.


VAERS ID: 1366857 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Female  
Location: Virginia  
Vaccinated:2021-05-29
Onset:2021-06-02
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-06-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Heavy menstrual bleeding, Menstruation irregular
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Fertility 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: Ibuprofen
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data:
CDC Split Type:

Write-up: Got period 2 weeks early days after vaccine that?s heavier than normal


VAERS ID: 1367463 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Virginia  
Vaccinated:2021-06-01
Onset:2021-06-02
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Private       Purchased by: ?
Symptoms: Chills, Dehydration, Full blood count, Laboratory test, Nausea, Pyrexia, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (narrow)

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: none
Current Illness:
Preexisting Conditions:
Allergies: nkda
Diagnostic Lab Data: cbc/chem/iv hydration.
CDC Split Type:

Write-up: body aches, nausea,, subjective fever/chills, near syncope.


VAERS ID: 1367694 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Female  
Location: New Jersey  
Vaccinated:2021-06-02
Onset:2021-06-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 014M20A / 1 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Product storage error
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:
CDC Split Type:

Write-up: Employee, Medical assistant took Moderna from freezer and without waiting the 2.5 hours, he drew vaccine and injected into patients arm. I I have spoke with the patient today after she left to make sure she was not feeling any unusual side effects. I am not sure of what the proper protocol is for this error is. I called the Moderna hotline and they really could not assist me in this matter.


VAERS ID: 1367696 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Male  
Location: Michigan  
Vaccinated:2021-06-02
Onset:2021-06-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1808982 / 1 LA / IM

Administered by: School       Purchased by: ?
Symptoms: Injection site haemorrhage, Injection site swelling
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: unknown
Current Illness: unknown
Preexisting Conditions: unknown/not reported
Allergies: denies
Diagnostic Lab Data: na
CDC Split Type:

Write-up: near immediate lump at injection site. minimal bleeding when withdrawing needed. lump measured at injection site 18 mm x 13 mm. no active bleeding, no erythema or bruising. Spoke to patient for 8 minutes during which time no additional signs or symptoms were noted. Discussed next steps. Will call to check on status in 4-5 hours and again in 20-24 hours. Advised to contact our clinic or PCP with any additional questions or concerns. Has appt with PCP 6/3/21 for annual PE. Advised to monitor site periodically.


VAERS ID: 1367706 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Male  
Location: New York  
Vaccinated:2021-06-02
Onset:2021-06-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 206A21A / 1 LA / IM

Administered by: Other       Purchased by: ?
Symptoms: Needle issue, Underdose
SMQs:, Medication errors (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: albuterol, zyrtec
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: When going to inject vaccine, needle was inserted into arm and when the syringe was depressed the needle retracted immediately, sending most of the vaccine down the patients arm and leaving some in the barrel, it is believed to be less than half the dose administered therefore a second full dose of vaccine was administered in the opposite arm.


VAERS ID: 1367713 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Male  
Location: Rhode Island  
Vaccinated:2021-06-02
Onset:2021-06-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 206A21A / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Anxiety, Condition aggravated, Dizziness, Nervousness
SMQs:, Anticholinergic syndrome (broad), Vestibular disorders (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: None
CDC Split Type:

Write-up: After giving vaccine, patient was in observation area and stated he felt light headed. He was nervous about the vaccine and feeling anxious. After speaking with him, he calmed down and stated he normally gets anxious regarding immunizations. He sat for 20 minutes and felt fine enough to go home.


VAERS ID: 1367729 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Male  
Location: New York  
Vaccinated:2021-06-01
Onset:2021-06-02
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Penile pain
SMQs:

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: Pain in my penis.


VAERS ID: 1367750 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Female  
Location: California  
Vaccinated:2021-06-02
Onset:2021-06-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 024C21A / 2 LA / IM

Administered by: Other       Purchased by: ?
Symptoms: No adverse event, 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? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: Unknown
Allergies: None
Diagnostic Lab Data: None
CDC Split Type:

Write-up: 17 year old given 2nd dose of Moderna COVID-19 vaccine. No physical adverse event.


VAERS ID: 1367753 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Male  
Location: Minnesota  
Vaccinated:2021-06-02
Onset:2021-06-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Private       Purchased by: ?
Symptoms: Dizziness, Peripheral swelling, Pruritus
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Vestibular disorders (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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Amitriptyline Ibuprofen Vitamin D3 Vitamin B12
Current Illness: MS
Preexisting Conditions: MS
Allergies: PCN
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient received first dose of Pfizer vaccine and waited 30 minutes after. About 28 minutes later developed itching to forearms and swelling in hands. EMT gave IV Benadryl and patient became dizzy- transported to ED


VAERS ID: 1367756 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Male  
Location: Maryland  
Vaccinated:2021-06-02
Onset:2021-06-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0186 / 2 LA / IM

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Fall, Hyperhidrosis, Pallor, Presyncope
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Accidents and injuries (narrow), 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? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Dizziness-Fell from chair to floor. Pale, diaphoretic-vasovagal. Moved from floor to stretcher by EMS, brought to med screening for evaluation. B.P :103/60 Rechecked 116/74. Left in stable condition at 12:53 . Recorded by RN and Medic.


VAERS ID: 1367770 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-06-02
Onset:2021-06-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 037B21A / 1 LA / IM

Administered by: Public       Purchased by: ?
Symptoms: Swollen tongue
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Oropharyngeal allergic 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? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: OCP Ariprozole 20 mg qd, Pantropozole20 mg qd, Sertraline 200 mg qd, Prazosin 1 mg qpm Trazadone 50 mg qpm
Current Illness: none
Preexisting Conditions: Depression and anxiety
Allergies: Celery, Mustard
Diagnostic Lab Data: N/A
CDC Split Type:

Write-up: Pt c/o tongue swelling without difficulty breathing, EMS called . Epinephrine 0.3mg administered. EMS arrived,swelling less . After discussion with EMS and mother pt agreed to transport to Hospital.


VAERS ID: 1367772 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Male  
Location: Oregon  
Vaccinated:2021-06-02
Onset:2021-06-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0186 / 2 LA / IM

Administered by: Public       Purchased by: ?
Symptoms: Interchange of vaccine products
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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient received a mixed series. Initially got Moderna, came in and was given Pfizer for a second dose. Client counseled and doing well after injection wait time.


VAERS ID: 1367783 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Female  
Location: New York  
Vaccinated:2021-05-31
Onset:2021-06-02
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-06-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Abdominal discomfort, Abdominal tenderness, Burning sensation, Chills, Cough, Dry skin, Erythema, Injection site erythema, Injection site pain, Injection site swelling, Lipase increased, Lymphadenopathy, Pancreatitis acute, Productive cough, Pyrexia, Rash, Rash erythematous, Respiratory tract irritation, Skin warm, Tenderness
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (narrow), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Infective pneumonia (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: Past Medical History: Diagnosis Date ? Allergic rhinitis ? Asthma ? Asthma ? Chronic neck pain ? Duodenitis ? Gastroparesis ? GERD (gastroesophageal reflux disease) ? Herniated disc, cervical ? Hiatal hernia ? Obesity ? Renal stones ? Stomach ulcer ? Stress incontinence ? Uterine fibroid
Allergies: Amlodipine Not Specified Unknown Reaction Chicken Allergy Not Specified Unknown Reaction Chicken and turkey Ciprocinonide [fluocinolone] Not Specified Hives Ciprofloxacin Hcl Not Specified Unknown Reaction Codeine Not Specified GI Reaction Doxycycline Not Specified Unknown Reaction Environmental Not Specified Unknown Reaction Flovent Hfa [fluticasone] Not Specified Unknown Reaction Latex Not Specified Unknown Reaction Morphine Not Specified GI Reaction Percocet [oxycodone-acetaminophen] Not Specified Unknown Reaction Prednisone Not Specified Unknown Reaction Vicodin [hydrocodone-acetaminophen] Not Specified GI Reaction Whey Protein [cardiowhey] Not Specified GI Reaction Wool Alcohol [anhydrous Lanolin]
Diagnostic Lab Data: 6/2/21 lipase 997 U/L
CDC Split Type:

Write-up: Patient is a 56-y.o. female with PMH of GERD who states that since receiving a COVID-19 vaccination 2 days ago has had progressive swelling, aching and redness in her left arm where she received the vaccination. Complains of associated lymph node swelling under her left arm and into her neck. Also complained of onset of phlegmy cough and some burning in her lungs associated with her asthma. Additionally complained of burning discomfort in her upper abdomen. Denied associated nausea, vomiting or diarrhea. States she has had some low-grade fever and chills. Musculoskeletal: General: Swelling ( Left arm with mild swelling, erythema and tenderness) present. No deformity. Normal range of motion. Cervical back: Normal range of motion and neck supple. Lymphadenopathy: Cervical: Cervical adenopathy present. Left cervical: Superficial cervical adenopathy present. Upper Body: Left upper body: Axillary adenopathy present. Skin: General: Skin is warm and dry. Findings: Rash ( Burning red rash on the outside aspect of both feet) present. No erythema. 56-y.o. yr old patient with PMH of hypertension and asthma presenting with adverse reaction to COVID-19 vaccination including acute pancreatitis. Lab work showed elevated lipase of 1000, and on examination she had epigastric tenderness: Admitted with acute pancreatitis, and was started on IV fluids


VAERS ID: 1367836 (history)  
Form: Version 2.0  
Age: 19.0  
Sex: Female  
Location: Virginia  
Vaccinated:2021-06-02
Onset:2021-06-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 003C21A / 2 LA / IM

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Seizure
SMQs:, Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Vestibular disorders (broad), Generalised convulsive seizures following immunisation (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: Zoloft, Olanzapine, Aurovela
Current Illness:
Preexisting Conditions: Functional Neurologic Disorder, Pseudoseizures
Allergies: Amoxacillin- hives
Diagnostic Lab Data:
CDC Split Type:

Write-up: Seizure activity noted within 30 minutes of vaccination. Pt known to have functional neurologic disorder and pseudoseizures daily (sometimes back-to-back). Pt alert and orientedx4. Pt dizzy and states she did not eat lunch today. Provided with water and granola bar. Second seizure noted 20 minutes later. Pt stayed for observation for additinal 40 minutes following second seizure. Client refused transportation to hospital and clients brother came to pick her up.


VAERS ID: 1367909 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Male  
Location: Massachusetts  
Vaccinated:2021-06-01
Onset:2021-06-02
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 054C21A / 2 LA / SC

Administered by: Other       Purchased by: ?
Symptoms: Chills, Fatigue, Hyperhidrosis, Injection site pain, Oropharyngeal pain, Pain
SMQs:, Neuroleptic malignant syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Extravasation events (injections, infusions and implants) (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Serouill , valium, Zoloft,singular,advair,combivent respimat,
Current Illness: Asthma with complications
Preexisting Conditions: Asthma with complications lung disease mental illness
Allergies: Bees
Diagnostic Lab Data: None have not contacted doctor yet
CDC Split Type:

Write-up: severe fatigue with wide spread pain, sore throat , arm pain at injection site, chills,sweating


VAERS ID: 1367938 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-05-24
Onset:2021-06-02
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-06-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002187 / 1 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Pain in extremity, Peripheral swelling, Rash erythematous, Rash pruritic, Skin warm, Vaccination site rash, Vaccination site reaction
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), 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: Synthroid
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: The day after my arm was significantly swollen and painful but it wasn''t too bad. Today I woke up with a red circular rash around the vaccine site that''s approximately 3 inches in diameter. It''s red, hot and itchy.


VAERS ID: 1367946 (history)  
Form: Version 2.0  
Age: 62.0  
Sex: Female  
Location: Maryland  
Vaccinated:2021-06-01
Onset:2021-06-02
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 204AA21A / 1 RA / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Dorozolamide eye drops for glaucoma
Current Illness: n/a
Preexisting Conditions: glaucoma & over weight
Allergies: shell fish , sulphur drugs & dust , pollen etc
Diagnostic Lab Data: have not went to doctors yet just discovered
CDC Split Type:

Write-up: Noticing a small lump under skin on right collar bone by feeling or touch


VAERS ID: 1367973 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Minnesota  
Vaccinated:2021-06-01
Onset:2021-06-02
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0187 / 1 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Diarrhoea, Discomfort, Headache, Nausea, Pain, Pain in extremity
SMQs:, Acute pancreatitis (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: N/A
Current Illness: Covid 19
Preexisting Conditions: Irritable bowel syndrome
Allergies: Skin allergies to bleach , latex , and adhesive.
Diagnostic Lab Data: N/A
CDC Split Type:

Write-up: Severe diarrhea , nausea , severe pain and soreness in left arm , discomfort and headache.


VAERS ID: 1367987 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Male  
Location: California  
Vaccinated:2021-06-01
Onset:2021-06-02
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 006021A / 2 RA / IM
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 050C21A / 1 RA / IM

Administered by: Other       Purchased by: ?
Symptoms: Musculoskeletal stiffness, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: sore arm and shoulder 1st injection
Other Medications: none
Current Illness: None
Preexisting Conditions: Seasonal Allergies
Allergies: none
Diagnostic Lab Data: none
CDC Split Type:

Write-up: Stiff arm, current low grade fever 99.7


VAERS ID: 1367991 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Female  
Location: Wisconsin  
Vaccinated:2021-06-01
Onset:2021-06-02
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 RA / IM

Administered by: Private       Purchased by: ?
Symptoms: Arthralgia, Diarrhoea, Injection site pain, Nausea
SMQs:, Acute pancreatitis (broad), Pseudomembranous colitis (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Arthritis (broad), 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: Levothyroxine, Celexa, gabapentin, lorzapam
Current Illness: none
Preexisting Conditions: hypothyroid
Allergies: none
Diagnostic Lab Data: none
CDC Split Type:

Write-up: Scale of 1-10. 10 being severe. 1:30 am joint pain, 5; site tenderness, 4; nausea, 3. Joint pain lessened by 12 pm on 06/02. Nausea worsened all day on 06/02. Loose stools 11 times that same day.


VAERS ID: 1367994 (history)  
Form: Version 2.0  
Age: 64.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-06-02
Onset:2021-06-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0162 / 1 RA / IM

Administered by: Private       Purchased by: ?
Symptoms: Arthralgia, Dizziness, Dyspnoea, Headache, Heart rate increased, Neck pain
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Arthritis (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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: lisinopril 20 mg daily diclofenac sodium 75mg daily Levothyroxine 0.75mcg daily
Current Illness: none
Preexisting Conditions: hypertension thyroid problems
Allergies: codeine PCN
Diagnostic Lab Data: none
CDC Split Type:

Write-up: 11:55am-10 minutes after receiving the vaccine patient complained of "heart beating a little fast, SOB and feeling woozy". Ambulance was called. BP-115/72, pulse 88, pulse ox 99%, resp 14. 11:59am- LPN administered one 81 mg chewable aspirin per Dr''s request. BP 124/72, pulse 83, pulse ox 99%, resp 14. 11:58am-IV started with NS at KVO per RN. O2 per NC at 2L. Patient c/o neck, left shoulder and head pain. 12:10pm-81 mg chewable aspirin given per Dr''s orders. Ambulance arrived and patient transported to Hospital. Husband notified to meet patient at hospital.


VAERS ID: 1368000 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-06-02
Onset:2021-06-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0191 / 2 LA / IM

Administered by: Other       Purchased by: ?
Symptoms: Anxiety, Dizziness, Immediate post-injection reaction
SMQs:, Anticholinergic syndrome (broad), Vestibular disorders (broad), Hypersensitivity (narrow), 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: Felt dizzy immediately post first dose covid 19 vaccine (Pfizer) on May 12, 2021
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Pulse 86 Respirations 18 SPO2 100% BP 118/72 Exam was normal
CDC Split Type:

Write-up: Felt dizzy immediately post vaccination (same thing happened after the first dose) Patient stated she felt anxious about vaccine, felt dizzy and wanted blood pressure checked. Patient was given water, symptoms resolved within several minutes Discharged to home with son


VAERS ID: 1368005 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Female  
Location: Maryland  
Vaccinated:2021-06-02
Onset:2021-06-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 206A21A / 1 RA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: 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: n/a
Current Illness: none
Preexisting Conditions: none
Allergies: no allergies
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient was given 0.5mL of Janssen vaccine IM into her right deltoid muscle. Post vaccine patient, fainted during the 15 minute wait period. She was promptly attended to, and did not exhibit signs of anaphylaxis. EMS came to assess patient even though she felt "completely normal" after she fainted.


VAERS ID: 1368007 (history)  
Form: Version 2.0  
Age: 20.0  
Sex: Male  
Location: Wisconsin  
Vaccinated:2021-06-02
Onset:2021-06-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0191 / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Dizziness, Hyperhidrosis, Loss of consciousness, Nervousness
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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient slumped over in waiting chair shortly after vaccination. Felt like he was going to pass out he said, he got really sweaty and a little shaky. He slumped over twice for about 3 seconds each time, but he was easily woken up and was able to tell me his name. His symptoms lasted about 15 minutes after his vaccination. He drank some water and had some candy. He felt much improved.


VAERS ID: 1368014 (history)  
Form: Version 2.0  
Age: 12.0  
Sex: Female  
Location: Massachusetts  
Vaccinated:2021-06-02
Onset:2021-06-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0185 / 1 - / IM

Administered by: Private       Purchased by: ?
Symptoms: Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Sertraline, probiotic, vitamin D, Vitamin B supplement, Neuroflam supplement. l-theanine, Claritin nystatin 21 day course she completed on 5/29/21 Azithromycin was completed 10 days before vaccine.
Current Illness: Took antibiotics recently because it had dental work and doctor had advised it as a precaution. Took Nystatin because had fungal infection after antibiotic. She had a cold (negative Covid test) about 2 wks ago. Cold was resolved last week, she had a fever with this, and that was 13 days prior to the vaccine.
Preexisting Conditions: PANDAs
Allergies: PCN- rash and joint inflammation. Dust mites, mold, mild to pet dander.
Diagnostic Lab Data: none
CDC Split Type:

Write-up: Rash on torso and legs


VAERS ID: 1368015 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Female  
Location: North Carolina  
Vaccinated:2021-06-02
Onset:2021-06-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0168 / UNK RA / IM

Administered by: Public       Purchased by: ?
Symptoms: Axillary pain, Blood pressure increased, Chest pain, Dizziness, Presyncope, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypertension (narrow), 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: none
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient reports sharp pain in left upper chest area and into the under arm area and reports she may pass out. Patient had a vasovagal syncope episode followed by vomiting. After 30 mins of resting, she reports she was no longer lightheaded or nauseous. Chest pain resolved. Patient does report headache at departure. 12:53 - BP 152/82, P-73, R-20, Pulse Ox-97%. 13:00 - BP 140/80, P-87, R-20, Pulse Ox-100%. 13:10 - 122/78.


VAERS ID: 1368027 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Male  
Location: Florida  
Vaccinated:2021-06-01
Onset:2021-06-02
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 033B21A / 2 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Injection site pain, Pain, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (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: Lisinopril, COREG, low-dose aspirin
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data: None
CDC Split Type:

Write-up: 100.2 fever, body aches, sore injection site.


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